Development Engineer (Product Quality) 

Process Engineering Manager

Site Quality Leader

Admin Support (Executive Assistant)

Associate Director RA & QA

DEA Manager

EHS Manager

VP, IAM Assurance Leader

Senior Manager - Portfolio Development

Warehouse Technician

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>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: <ul><li>To coordinate and facilitate meetings, ensuring accurate documentation through comprehensive minute-taking and timely distribution.&nbsp;</li><li>Manage visa application requests, end-to-end accommodation, travel arrangements, and logistical support for staff and visitors, ensuring efficiency, cost-effectiveness, and a seamless experience.</li><li>Responsible and liaise with 3rd party service providers to ensure timely and compliant processing of Professional Visit Pass (PVP) application for both staff and external vendors.</li><li>Manage with 3rd party service providers to ensure accommodation arrangements for long-stay foreign staff and vendors, including housing setup (apartment, condominium, or staff house), utility provisioning, and food delivery coordination.&nbsp;</li><li>Participate in internal and external audits, ensure timely closure of audit findings with proper documentation and evidence.</li><li>Ensure adherence to company policies and regulatory requirements, maintaining compliance across all administrative and operational activities.</li><li>Coordinating with the canteen service provider to ensure consistent food quality, hygiene and food quantity to meet the daily operation’s needs and to audit canteen timely manner and attend external audit if needed.</li><li>Manage telephone system and deal with service provider if having issue.</li><li>To manage office furniture. To deal with vendor and raise purchase requisition for new added or replacement.</li><li>Actively engage in safety, quality and compliance programs while providing comprehensive administrative support to operations.&nbsp;</li><li>Serve as the primary contact for internal departments and external suppliers in managing administrative matters with efficiency and professionalism.</li><li>Verify and review service provider / vendor billings to ensure accuracy, compliance with contractual terms, and timely processing.</li></ul> Requirements: <ul><li>Degree in business administration or related field.</li><li>Several years of experience working in an administrative role.</li><li>Effective communication skills in multiple languages, both written and verbal to engage with different level of employees and service providers across diverse regions.</li><li>Basic knowledge of office management systems and procedures.</li><li>Proficiency in MS Office (Word, Excel, PowerPoint).</li><li>Ability to handle sensitive information confidentially.</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 DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

Responsibilities: EHS Strategy &amp; Leadership: <ul><li>Develop, implement, and maintain a comprehensive EHS management system aligned with company goals and regulatory requirements.&nbsp;</li><li>Integrate EHS strategy into broader business planning and participate in leadership meetings to influence decision-making.&nbsp;</li><li>Lead change management initiatives to build a proactive safety culture across all levels of the organization.</li></ul> Risk Management &amp; Compliance: <ul><li>Conduct and advise on risk assessments, quantify and prioritize risks, and implement effective control measures.&nbsp;</li><li>Ensure compliance with OSHA, EPA, and other relevant local, state, and federal regulations.&nbsp;</li><li>Oversee contractor and visitor safety programs, including onboarding and compliance tracking.</li></ul> Training &amp; Engagement: <ul><li>Design and deliver engaging EHS training programs tailored to various roles and risk profiles.&nbsp;</li><li>Promote employee engagement through behavior-based safety (BBS), ergonomics, and wellness initiatives.&nbsp;</li><li>Champion inclusive safety practices that consider diverse employee needs and backgrounds.</li><li>Emergency Preparedness &amp; Crisis Management: Develop and maintain emergency response plans, conduct drills, and coordinate with local emergency services.&nbsp;</li><li>Lead crisis management efforts, including communication protocols and post-incident reviews.</li></ul> Environmental Sustainability: <ul><li>Implement and monitor environmental sustainability programs, including waste reduction, energy efficiency, and water conservation.</li><li>Audits, Inspections &amp; Continuous Improvement: Conduct regular audits and inspections to identify hazards and ensure compliance.&nbsp;</li><li>Use data analytics and digital tools to track performance, identify trends, and drive continuous improvement.</li><li>Hazardous Materials &amp; Waste Management: Oversee safe handling, storage, and disposal of hazardous chemicals and waste.&nbsp;</li><li>Ensure proper documentation and training related to chemical safety and spill containment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Safety, Industrial Engineering, or related field</li><li>7+ years’ experience, including 2+ years of progressive people management experience - (equivalent experience may be considered).</li><li>Proven experience in chemical handling, technical operations, and regulatory compliance.</li><li>Strong knowledge of OSHA, EPA, ISO standards, and other applicable regulations.</li><li>Proficiency in EHS software platforms and data analytics tools. Demonstrated leadership, communication, and team-building skills.</li><li>Ability to manage projects, influence cross-functional teams, and drive cultural transformation.</li></ul>

Responsibilities: <ul><li>Create and Maintain Strategic Roadmaps: Develop and execute multi-year roadmaps to drive innovation, strengthen security posture, meet regulatory requirements, and streamline IAM operations—specifically for IAM assurance capabilities, control monitoring, and evidence automation.</li><li>Stakeholder Engagement: Build and nurture strong relationships across Security Operations, Technology Teams, Governance, Operational Risk, and Internal Audit, ensuring program alignment, audit readiness, and the ability to clearly demonstrate IAM control effectiveness to stakeholders and regulators.</li><li>Risk and Progress Management: Identify, assess, and mitigate technical and organizational risks while regularly reporting blockers, corrective actions, and program milestones to executive leadership; ensure timely remediation of control gaps and recurring defects.</li><li>Solution Design &amp; Automation: Lead and contribute to designing technical solutions for complex automation use cases, driving operational efficiency and scalability—especially automation to detect, track, and remediate IAM control defects.</li><li>Program Integrity: Ensure standards, policies, and procedures are accurately documented and officially maintained for audit and compliance requirements; recommend updates to IAM standards based on security threats, regulatory expectations, and industry trends.</li><li>Performance Tracking: Define, implement, and monitor Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to measure program maturity and overall effectiveness, including assurance coverage, control pass rates, remediation SLAs, defect recurrence, and reporting timeliness/accuracy.</li><li>Assurance Operations Leadership: Lead assurance activities to track, validate, and remediate key logical access and authentication controls across centralized IAM services (e.g., Active Directory, Oracle LDAP, Beyond Identity) and decentralized implementations as applicable.</li><li>Assurance Reporting Platform Ownership: Manage and evolve the IAM assurance reporting platform(s) used to monitor adherence to company standards, control design, and operational effectiveness; ensure reporting is accurate, resilient, and audit-ready.</li><li>Agile Partnership with Product Owners: Partner with IAM product owners and delivery teams using Agile methodologies to prioritize and implement control improvements, balancing risk reduction with service stability and customer impact.</li><li>Control Evidence &amp; Audit Support: Ensure the organization can efficiently produce high-quality evidence for SOX, PCI, and other examinations; proactively address audit issues with root-cause correction and sustainable control improvements.</li><li>Documentation &amp; Enablement: Oversee creation, maintenance, and review of operational process documentation and end-user/training materials needed to support consistent execution of IAM assurance activities.</li><li>Problem Resolution: Independently resolve technical challenges while escalating issues with clarity when necessary.</li><li>Perform other critical duties or special projects as assigned.</li></ul> Requirements: <ul><li>BS/BA in Computer Science, Information Technology, Cybersecurity, Business Management, or equivalent, plus 10+ years IT experience, OR in lieu of a degree with 12+ years IT experience demonstrating progressive responsibility.</li><li>Minimum 5 years of experience leading multiple IAM service products (e.g., authentication, privileged access, identity governance) and driving outcomes across both centralized and distributed service models.</li><li>Minimum 5 years of experience developing and improving IAM service processes and reporting on IAM service key controls (design and operating effectiveness).</li><li>Minimum 3 years leading operations or assurance teams, including continuous monitoring, issue management, and control remediation.</li><li>At least 2 years working with Agile methodologies in roles such as Product Owner, Scrum Master, or Technical Lead.</li><li>Minimum 2 years of people management experience, leading teams of 2+ engineers or contractors.</li></ul>

Key Responsibilities: Global Portfolio Strategy <ul><li>Define and implement a unified global portfolio vision to meet future consumer/customer needs for filters and beyond filters (combustibles and next generation products)</li><li>Direct multi category program and project management to ensure innovation efforts are focused towards building a healthy portfolio</li><li>Balance global consistency with regional customization to maximize market relevance and profitability.</li><li>Oversee portfolio lifecycle management, including launches, rationalization, and category transitions.</li></ul>&nbsp;Market &amp; Consumer Insights <ul><li>Lead global research initiatives to capture consumer trends, competitive intelligence, and regulatory shifts across regions.</li><li>Translate insights into global portfolio strategies and innovation pipelines</li></ul> Innovation &amp; Product Development <ul><li>Drive global innovation programs, ensuring new products meet consumer demand and comply with international regulations.</li><li>Be the one stop shop for innovation – where commercial team and customers channel their initial ideas and requests before being formalized into innovation projects</li></ul>&nbsp;Cross-Regional Leadership <ul><li>Align regional commercial directors and managers under a global framework.</li><li>Facilitate knowledge sharing and best practices across markets to accelerate growth.</li><li>Act as the key liaison between commercial, operations and innovations teams</li></ul>&nbsp;Regulatory &amp; Compliance Oversight <ul><li>Monitor and interpret global regulatory developments impacting tobacco categories.</li><li>Ensure portfolio decisions adhere to international laws, trade agreements, and corporate responsibility standards.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s degree in engineering ,Business, Marketing, Economics, or related field; MBA strongly preferred.</li><li>12+ years of experience in FMCG, tobacco, or regulated industries, with at least 5 years in global portfolio/category leadership.</li><li>Deep understanding of international tobacco industry dynamics, consumer behavior, and regulatory frameworks.</li><li>Proven track record in global strategic planning, innovation, and cross-market leadership.</li><li>Exceptional communication, negotiation, and stakeholder management skills across diverse cultures.</li></ul>&nbsp;Competencies <ul><li>Strategic global mindset with commercial acumen.</li><li>Ability to balance global consistency with local market needs.</li><li>Leadership and team development across geographies.</li><li>Strong influencing skills in complex stakeholder environments.</li><li>Ethical decision-making and commitment to responsible global business practices.</li></ul>

Role Description: <ul><li>The Warehouse Technician will be responsible for executing material handling, inventory management, and warehouse operations in support of a sterile pharmaceutical manufacturing facility producing injectable IV bag products, including high potent APIs and controlled substances.</li><li>This role will ensure materials are received, stored, issued, and shipped in compliance with cGMP, DEA, and site safety requirements.</li><li>The Warehouse Technician will play a key role in maintaining accurate inventory records, supporting production schedules, and ensuring the cleanliness, organization, and security of the warehouse.</li></ul> Responsibilities: <ul><li>Receive, inspect, and verify incoming materials, components, and supplies against purchase orders and specifications.</li><li>Ensure proper storage of raw materials, packaging components, and controlled substances in compliance with cGMP, DEA, and safety requirements.</li><li>Accurately issue and deliver materials to production areas based on production schedules and work orders.</li><li>Operate warehouse equipment such as forklifts, pallet jacks, and material handling devices in a safe and compliant manner.</li><li>Perform cycle counts, physical inventory counts, and reconciliation of discrepancies in coordination with Inventory Control.</li><li>Maintain warehouse cleanliness, organization, and environmental conditions per site procedures and regulatory requirements.</li><li>Document all material transactions in the inventory management system, ensuring data accuracy and adherence to data integrity principles.</li><li>Prepare shipments of materials, components, or finished products in compliance with applicable regulations, including hazardous material handling requirements.</li><li>Support material sampling activities, including coordination with Quality Control for testing.</li><li>Assist in warehouse procedure creation, updates, and continuous improvement initiatives.</li><li>Ensure DEA security and access control measures are followed for controlled substances.</li><li>Collaborate with Production, Quality, Planning, and Procurement to ensure timely material availability for manufacturing operations.</li></ul> Requirements: Qualifications/Experience: <ul><li>High school diploma or equivalent required; Associate’s degree preferred.</li><li>Minimum of 2 years of warehouse or material handling experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience handling controlled substances and/or high potent APIs preferred.</li><li>Knowledge of cGMP, DEA, and OSHA requirements for material handling and storage.</li><li>Experience operating forklifts and other warehouse equipment; forklift certification preferred.</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and accuracy in documentation and inventory management.</li><li>Familiarity with inventory management systems and ERP software.</li><li>Ability to work effectively in a fast-paced, highly regulated environment.</li><li>Strong organizational skills with the ability to prioritize tasks.</li><li>Good communication and teamwork skills.</li><li>Commitment to safety, compliance, and maintaining a secure warehouse environment.</li><li>Ability to lift and move materials in accordance with safety guidelines.</li></ul>

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52 regulatory affairs Jobs found

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

Admin Support (Executive Assistant)

Associate Director RA & QA

DEA Manager

EHS Manager

VP, IAM Assurance Leader

Senior Manager - Portfolio Development

Warehouse Technician

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52 regulatory affairs Jobs found

Development Engineer (Product Quality)

Process Engineering Manager

Site Quality Leader

Admin Support (Executive Assistant)

Associate Director RA & QA

DEA Manager

EHS Manager

VP, IAM Assurance Leader

Senior Manager - Portfolio Development

Warehouse Technician

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