Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Development Engineer (Product Quality) 

Process Engineering Manager

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Project Manufacturing Leader

VP,  Senior Audit Manager

Responsibilities: <ul><li>Lead a global team of Advanced Quality Engineers in support of all new product introductions for a Strategic Product Line Portfolio within the Digital Data Networks (DDN) business unit. Lead all AQE activities from project inception to product launch and introduction.</li><li>Participate in the project Kick-off Meetings, support project team development for internal requirements, customer specific requirements, Risk Priority Number (RPN) reductions, analyze SPC data, etc.</li><li>Serve as the liaison between engineering and the plants on new product introductions to ensure robust process capability on all programs.</li><li>Attend project meetings and APQP driven events with the customers and the Project/Program Management Team.</li><li>Document the results for specific program characteristics and ensure the internal and external requirements are met including deviations.</li><li>Accountable for developing and driving on time delivery of Control Plans, Capability Studies, Part drawings, Inspection Instructions, Gage design and R&amp;R, DFMEAs, PFMEAs, AFMEAs for all assigned projects. Ensure the products developed are Designed for Manufacturing &amp; Assembly (DfMA) and are launched capably of meeting internal requirements and customer requirements.</li><li>Understand product requirements and define/approve Design Validation Test (DVT) and quality plans to ensure products meet the product specifications.</li><li>Authorize and approve that all Design Validation Test (DVT) results meet product specifications and customer requirements.</li><li>Actively participate in early product Concept Reviews and Design Review meetings with the Product Development Engineering (PDE) for the assigned product, related tooling and fixturing, and overall quality plans.</li><li>Generate and/or champion 8-Ds for the prototype process including 8-Ds for problem solving, test failures, and prototype failures.</li><li>Complete the Change Control process and identify special characteristics for projects/programs.</li><li>Work in conjunction with the Manufacturing Process Development Engineering (MPDE) teams to ensure the manufacturing process and equipment meets the product’s defined quality level and that the process also meets the capability levels identified for the product and project.</li><li>Assemble and submit PPAP package on time to the customer specific requirement.</li><li>Team with Supplier Quality Engineers to conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR), support completion of Supplier PPAPs.</li><li>Perform Six Sigma Capability Analysis of new equipment/processes to reduce variation.</li><li>Regularly reports to executive management on the overall performance and effectiveness of the Global Supplier Quality Program.</li><li>Drive high performance organization by providing your team routine coaching and feedback, holding your team accountable to meet performance objectives, and providing meaningful development to increase individual/team capability.</li><li>Manage employee well-being by prioritizing work, effectively managing resource loading, and providing flexibility to enable employees to successfully balance their work and personal lives.</li><li>Drive organization effectiveness by structuring your organization in a way that best enables the BU strategy, maximizes resource efficiency and productivity, and provides role clarity and clear lines of accountability.</li><li>Manage the talent in your organization to support the business now and to proactively prepare for the future by identifying organization skillset/role gaps, implementing plans to fill any skillset/role gaps, and assessing current talent fit to ensure the right talent is matched to the right roles to best meet the needs of the business.</li></ul> Requirements: <ul><li>Bachelor/ Master’s degree in technical discipline (Electrical Engineering, Electronics, Mechatronics)</li><li>10+ years of Experience in Quality, Advanced Quality Engineering, and working in global organizations.</li><li>Experience managing engineering teams in cross-functional, multi-site global organizations to drive effectiveness across geographical boundaries and deliver projects with multiple dependencies and constraints.</li><li>Demonstrated ability to forge strong internal working relationships with senior functional counterpart leaders.</li><li>Experience in the use of Lean, Six Sigma, Design for Six Sigma (DFSS), Design for Manufacturability &amp; Assembly (DfMA), Kaizen, 8D and other advanced statistical methods including Design of Experiments (DoE), Statistical Process Control (SPC) and Process Capability (CpK) analysis techniques.</li><li>Comprehensive knowledge and understanding of departmental, company, and corporate procedures and systems, i.e. ISO9000, ISO9001, IATF16949, ISO14001, VDA, PPAP, DFMEAs, PFMEAs, APQP Gate Reviews, GD&amp;T.</li><li>Excellent verbal and written communication skills and the ability to interact professionally with customers, leadership, stakeholders, cross functional teams and subject matter experts.</li><li>Proven track record of being able to work on multiple demanding programs in parallel while maintaining on-time completion of all defined project tasks and deliverables.</li><li>Ability to prioritize responsibilities in a fast-paced dynamic work environment.</li><li>Willingness to travel as required, ~30%</li></ul>

Role Description: <ul><li>The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. </li><li>Has expert proficiency in conducting all types of physical and chemical analysis (including the most complex analysis) using all equipment. </li><li>This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemist.</li></ul> Responisbilities: Analysis &amp; Testing: <ul><li>Validate analytical methods for finished product and raw material release and stability testing.</li><li>Evaluates, troubleshoot/improves existing analytical methods when necessary.</li><li>Prepares method validation protocols, reports, and analytical test methods.</li><li>Performs testing to support process and formulation development (e.g. excipient, compatibility, solubility, dissolution studies, stability/impurity assessment)</li><li>Performs work to support project assigned with little oversight.</li><li>Presents analytical data to project team for review and discussion</li><li>Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test methods, validation protocols, or validation report) for completeness and compliance when necessary</li><li>Reviews and evaluates drug substance supplier’s technical documents to ensure internal testing test requirements are adequate.</li><li>Uses laboratory software for analysis.</li><li>Is alert to and detects abnormalities during performances of test and reviews.</li></ul> Lab Equipment: <ul><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals</li><li>Troubleshoots instrumentation and performs subsequent analyses</li></ul> Investigations: <ul><li>Evaluates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities</li><li>Participates in root cause identification of complex laboratory investigations.</li><li>Writes, edits, and reviews SOPs and laboratory investigations</li></ul> Training: <ul><li>Train junior Scientist/Chemists on analytical techniques.</li><li>Continuously updates knowledge with respect to the latest technologies related to analytical science</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li></ul> Compliance: <ul><li>Identifies need for SOPs and writes or revises, as appropriate</li><li>Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations</li><li>Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs</li><li>Takes active role in auditing laboratory logbooks/documentation to ensure compliance</li><li>Follows internal processes related to controlled substances</li></ul> Safety: <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR</li><li>Master’s degree in above disciplines with 4 years’ relevant analytical lab experience OR</li><li>PhD in above disciplines with some relevant analytical laboratory experience preferred</li></ul> Knowledge &amp; Skills: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: Program and Project Management <ul><li>Manage efforts and set the strategy for developing process technology for assigned products in Process R&amp;D.</li><li>Offer routine project coordination and technical support to your process development team.</li><li>Handle the demands of several customers to determine priorities for your team.</li><li>Resolve yield and defect issues related to your process area.</li><li>Collaborate with the Manufacturing Development Engineering team to meet R&amp;D product quality and cycle time goals.</li><li>Work with R&amp;D Management, Process Integration, and High-Volume Manufacturing Sites to regularly align on project requirements, priorities, and timelines.</li><li>Engage manufacturing sites, Manufacturing Integration, and Central Teams to provide technical direction and maintain alignment between production and R&amp;D.</li><li>Drive ongoing process and operational efficiency improvements to meet the needs of PI and manufacturing by actively interacting with the equipment development team and suppliers.</li><li>Interact with equipment and chemical vendors to ensure alignment and timely progress on our roadmaps, as well as foster a positive relationship.</li></ul> Performance Management <ul><li>Partner with direct reports to develop long/short-term goals and projects that meet the needs of the Technology Development department.</li><li>Offer ongoing feedback to your team members on performance, establishing a career plan and mentoring your team members to encourage their professional development.</li><li>Set and communicate performance goals for the team, and lead goal-based performance evaluations for all team members.</li><li>Mentor team members on technical as well as soft skills (presentation skills, risk management, decision making, vendor interaction, etc.)</li><li>Recognize and reward company team members for outstanding performance.</li><li>Recruit both external and internal candidates to fill headcount in the group.</li><li>Provide conflict resolution if issues arise.</li></ul> Requirements: <ul><li>PhD or Masters in Physics, Electrical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, along with at least 8 years of experience in the semiconductor industry concentrating on dry etch technology and managing personnel.</li><li>Bachelors degree in Physics, Electrical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, along with at least 15 years of experience in the semiconductor sector concentrating on Dry Etch technology and managing personnel.</li><li>At least five years of experience leading a process development team in a semiconductor R&amp;D or high-volume manufacturing environment.</li><li>Comprehensive understanding of Plasma Dry Etch Technology.</li><li>Knowledge and experience in high aspect ratio etch development.</li><li>Demonstration of collaborative ways of problem solving.</li><li>Understand hard mask requirements based on material properties.</li><li>Positive relationship building skills, both with internal and external customers.</li><li>Demonstrated structured problem-solving capabilities.</li><li>Strong communication and interpersonal skills (written, verbal, and presentation).</li><li>Experience in being a mentor to manage the performance of direct reports.</li><li>Ability to seek opportunities for continuous improvement, as a team member, leader, and for the organization.</li></ul>

Responsibilities: Customer Quality &amp; Technical Ownership: <ul><li>Act as the primary technical experts working closely with GQM, KQM, FSE, and internal stakeholders.</li><li>Lead customer complaint investigations, including root cause analysis using structured methodologies (e.g. 5 Whys, Fishbone, 8D), and ensure effective corrective and preventive actions (CAPA).</li><li>Ensure high-quality failure analysis (FA) reports supported by strong technical justification; challenge and close invalid or non-reproducible cases with data-driven rationale.</li><li>Drive fast response, structured escalation, and effective containment actions to improve response time and customer confidence.</li><li>Clearly translate customer complaints into technical, reliability, and risk-based problem statements.</li><li>Review customer quality documentation, including FAI, First Lot Approval, control plans, and inspection reports.</li><li>Ensure out-of-control situations are managed effectively through well-defined OCAPs, including timely containment and recovery actions.</li><li>Maintain high standards for 8D reports and monitor closure turnaround time to meet customer expectations.</li><li>Support regular customer quality reviews and maintain strong working relationships with key customer contacts.</li><li>Initiate internal technical quality improvement initiatives based on customer feedback, field failure data, and risk analysis.</li><li>Strengthen decision-making by identifying the most pragmatic solutions through cross-functional analysis of design, process, and supplier factors.</li></ul> Engineering &amp; Product Quality Assurance: <ul><li>Maintain strong product knowledge covering design intent, materials, machining, assembly, and related manufacturing processes.</li><li>Act as technical authority during escalations, challenging design or process decisions based on field data, reliability risk, and customer impact.</li><li>Support failure analysis and laboratory activities; convert findings into concrete design, process, or control improvements.</li><li>Serve as the link between field failures and design robustness, ensuring lessons learned are embedded into future products and updates.</li></ul> New Product Introduction &amp; Change Management: <ul><li>Participate in NPI and engineering change control processes to ensure customer quality, CTQ, and Copy Exact compliance.</li><li>Ensure customized or newly developed products fully meet customer specifications, quality standards, and regulatory requirements.</li><li>Provide engineering inputs for design reviews, DFMEA/DFMA, and quality guidelines from a customer and field reliability perspective.</li></ul> Culture &amp; Way of Working: <ul><li>Embody and promote company values: Integrity, Teamwork, Customer Centricity, and Innovation.</li><li>Foster a preventive mindset and risk-based thinking across engineering and quality activities.</li><li>Engage cross-functional teams with a clear focus on long-term product excellence and customer success.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical, Mechatronics, Manufacturing Engineering, or related field.</li><li>5–10+ years’ experience in customer quality, product engineering, or industrialization within high-mix, precision manufacturing (semiconductor equipment preferred).</li><li>Strong ability to read and interpret drawings, GD&amp;T, simulations, specifications, and tolerance concepts.</li><li>Hands-on experience with 8D, 5 Whys, Ishikawa, DFMEA/PFMEA, DFMA, SPC, MSA, DOE.</li><li>Strong analytical, system-level, and reliability-focused thinking.</li><li>Ability to challenge technical decisions fact-based and constructively.</li><li>Strong communication skills in English, including customer-facing and executive-level discussions.</li><li>Strong command of English for global-level communication. Proficiency in Mandarin Chinese (for Chinese customer interaction) and Malay (for shop-floor communication) is highly advantageous.</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</li></ul>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Role Description: <ul><li>The Project Manufacturing Leader is a Project Core Team Member, in charge of the industrialization of all client production lines involved in a project Value Stream, across several client plant locations when applicable.</li><li>The PML is responsible for achieving key targets in terms of Industrial Timing, Capacity, Quality and Production Costs in line with the Planisware Work packages and deliverables on time completion (or Project LeanPD milestones) requirements. His/Her role is to define and implement the best Production System and line Concepts while ensuring that all client Global Auto industrial strategy and standards are followed.</li><li>PML involvement with a new project starts at RFQ, between G0 and G1 and lasts until SOP + 3 months.</li><li>The PML reports directly to the regional ME organization, to the PML Manager/Director and functionally to the Project Manager.</li></ul> Responsibilities : Design for Manufacturing : <ul><li>The PML participates in the Product Design activities led by the Product Design Engineering Team, contributing towards reaching a product design compliant with client Industrial Targets and allowing maximum Production Profitability.</li><li>He/She leads Technology and comparative studies in case of multiple options and ensures that Process Feasibility is optimal and validated by experts.</li></ul> Footprint and Make or Buy Studies: <ul><li>With the support of his management and considering inputs from the project team, the PML conducts a preliminary footprint analysis, including Make or Buy comparative Studies.</li><li>The PML submits the proposal to the Regional/Global Industrial Strategy team for final decision.</li></ul> Production System Definition: <ul><li>(Plant: Production System, Physical lay-out) In the early program Development phase, the PML organizes, leads and follows-up the Lean Industrial Design workshop activity, involving all Project and Plant Team functions, under coordination of the ME or Launch Director.</li><li>Based on the initial industrial assumptions, he/she builds the initial Plant internal Material &amp; Information Flow Diagram (MIFD)/VSM, Line lay-out, Plant lay-out with Production System and Logistics areas footprint calculations.</li><li>Before Program CER/Capex Committee Meeting, he/she leads the Tool and machine Design Workshop, out of which plant delivers the detailed</li><li>Production Line layout and Advanced VSM. Confirm the proposed Production System including traceability and conformity.</li><li>PML leads the assessment of any equipment refurbishment needs for the project relying on the appropriate internal or external experts and validate the effective equipment refurbishment timing and cost with vendors.</li><li>Job Description The PML identifies any Industrial risk, defines a back-up plan for critical processes and provides Industrial Impact on any Engineering Change Request.</li></ul> Process FMEA: <ul><li>PML participates in the definition of Key Product Characteristics (KPC) and Key Control Characteristics (KCC) He/She coordinates and leads the PFMEA methodology during program phase with active participation of Process Experts, including PLTL or Process Engineer.</li><li>Once the initial PFMEA is completed, ensure that actions are implemented with all updates included prior to handover to the Plant at Mass Production Trial (MPT).</li></ul> CER Committee: <ul><li>(Product Manager initially presenting because of Commercial discussion then Project discussion) PML ensures Capacity analyses are completed prior to adding new equipment to the project.</li><li>He/She optimizes Project Investment through Reuse, Bundling, Massification etc. He/She builds and monitors the detailed Project Investment List.</li><li>He/She prepares and leads the Project CER/Capex industrial Presentation, submitting CER request and approval follow-up after Project and Plant Managers have validated the investments.</li><li>Once CER is presented, he/she ensures timely CER submission/validation and follow-up in line with the industrial timing.</li></ul> Industrial Timing: <ul><li>PML builds, updates &amp; monitors the complete Project Industrial timing plan for tools, equipment, Packaging, traceability and associated processes to meet all internal (MPT) and external Customer milestones on time and right first time, from specification to final acceptance.</li><li>He coordinates Project Product Engineers and Supply Chain Engineers within the Project Team and track Plants readiness status in collaboration with the Plant PLTL.</li><li>The PML coordinates Traceability Implementation, Machine and tooling acceptance, tracking improvement actions with a robust PDCA where needed. Responsible to organize Tooling &amp; Equipment progress status reviews involving the plant PLTL.</li></ul> Industrial Performance <ul><li>PML defines and tracks main Industrial Performance indicators: - MMR and Work Content - Scrap Process rate - Process Capabilities - Capacity Status and Process Cycle Time, including Equipment Utilization Monitoring (data from plant) - Rework monitoring - Material Yield - Launch Costs consolidated in the Business Plan - Project Investment PML ensures that the most suited technical solutions for Project Financial KPI improvement are investigated through standard, automation, digitalization with payback analysis.</li></ul> PAC reviews: <ul><li>Reporting PML reports progress status on Manufacturing Work Packages and related program milestones. All PMLs participate in the PML -or regional ME Department weekly routine.</li></ul> Requirements: <ul><li>Masters degree in engineering, or equivalent professional experience.</li><li>Minimum 5 years of proven experience in production or industrial area preferably in automotive sector.</li><li>Strong ability to work in an international and multicultural environment with complex matrix organization. Team building and positive mindset.</li><li>Leadership with ability to interact and coordinate complex subjects with technical teams. Proactive with a vision of long-term impact and problem anticipation.</li><li>Knowledge in project management process, Quality Control tools in production, Lean Line Design.</li><li>Result oriented with strong written, verbal communication skills. Fluent English required.&nbsp;</li></ul>

Responsibilities: <ul><li>Engage with India Leadership to understand emerging risk while providing risk themes and trends that can inform and help improve governance and control awareness.</li><li>Provide IA leadership to the Internal Audit team based in India by motivating and developing individuals to elevate quality and expand capabilities.</li><li>Assist with continuous monitoring activities related to Technology.</li><li>Supervise, manage, and motivate Audit Managers on scheduled audits.</li><li>Oversee audit planning and execution of audits including audit scoping, setting audit objectives, defining audit test steps, performing audit fieldwork and drafting audit reports.</li><li>Review and provide feedback to Audit Managers on the documentation of detailed process walkthroughs performed with management, including the identification of process risks and controls.</li><li>Review and provide feedback on detailed audit work papers performed during fieldwork, including control design and effectiveness testing.</li><li>Ensure Audit Managers have developed and documented clear audit work papers that succinctly articulate the process, risks, controls, test work performed, and conclusions reached.</li><li>Ensure effective and efficient execution of audits in conformance with professional and department quality standards.</li><li>Identify and articulate control gaps or control deficiencies.</li><li>Ensure timeliness of audit work and ensure audit is performed within budget.</li><li>Present audit results to various levels of internal audit leadership, as well as the business organization.</li><li>Contribute to risk assessment process and ongoing business/industry monitoring.</li><li>Maintain internal audit competency through ongoing professional development.</li><li>Oversee career and professional development of direct reports.</li><li>Perform other duties and/or special projects as assigned.</li></ul> Requirements: <ul><li>Bachelors or advanced degree in technology, business, or finance, with a minimum of 10+ years of relevant experience working within audit or a risk management function or minimum 12+ years relevant experience in lieu of a degree</li><li>Bachelor’s degree in Accounting, Auditing, or a technology-related degree with 9+ years of audit experience</li><li>5+ years in technology audit, controls, operations, and/or compliance</li><li>2+ years recent experience managing, supervising, and mentoring individuals</li><li>2+ years recent experience in leading projects and motivating teams</li><li>CISA/CISM/CPA/CIA/CRISC/CISSP certifications</li><li>Ability and flexibility to travel for business as required</li></ul>

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80 risk advisory Jobs found

Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Development Engineer (Product Quality)

Process Engineering Manager

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Project Manufacturing Leader

VP, Senior Audit Manager

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80 risk advisory Jobs found

Sr. Manager, Quality & Reliability Engineering

Scientist I, Quality Control LTS

Dry Etch Principal Engineer/ MTS Lead, Process Development, Advance NAND

Development Engineer (Product Quality)

Process Engineering Manager

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Project Manufacturing Leader

VP, Senior Audit Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.