Executive Assistant and Administrative Lead

Sr. Manager, Quality & Reliability Engineering

Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

TA Specialist

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

Responsibilities: Executive Support: <ul><li>Act as the primary point of contact for internal and external stakeholders on behalf of the MD.</li><li>Manage complex calendars, schedule meetings and appointments.</li><li>Prepare agendas, presentations, and reports for meetings.</li><li>Handle email correspondence and ensure timely responses.</li></ul> Travel Management: <ul><li>Liason with travel partner as SPOC for Travel Desk. Ensure timely wallet top up and accurate record-keeping. Manage Travel partner payment process and vendor management on SAP.</li><li>Arrange and coordinate domestic and international travel accommodations for the executives and others, including flight bookings, hotel accommodations, transportation, and itinerary planning.</li><li>Monitor travel itineraries, provide updates, and address any last-minute changes or emergencies.</li></ul> Confidentiality and Discretion: <ul><li>Handle sensitive and confidential information with intergrity, discretion and professionalism.</li><li>Maintain a high level of confidentiality in all aspects of the role.</li></ul> Compliance: <ul><li>Ensure 100% compliance on:&nbsp;</li><li>Vendor onboarding and documentation</li><li>Office safety protocols</li><li>Third-party office staff compliance</li><li>POSH training completion for all employees</li><li>Maintain accurate compliance records and provide periodic reports.</li></ul> Vendor Management: <ul><li>Oversee compliant and timely onboarding of vendors.</li><li>Supervise procurement quality assurance in SAP.</li><li>Ensure adherence to procurement policy from PO to Pay cycle.</li><li>Maintain accurate records for PO process, approvals, invoices, and agreements.</li></ul> Budgeting: <ul><li>Track monthly admin budget and ensure spend efficiency.&nbsp;</li><li>Provide 100% accurate monthly budget forecasting.&nbsp;</li><li>Monitor expenses and prepare reports for leadership review.</li></ul> Employee Engagement: <ul><li>Lead quarterly and annual R&amp;R programs, including trophy and certificate management.&nbsp;</li><li>Arrange and coordinate office events, meetings, and conferences, including logistics and catering arrangements.</li><li>Organize annual employee meets and engagement activities.&nbsp;</li><li>Ensure comprehensive onboarding for new joiners.</li></ul> Administrative Support &amp; Office Management: <ul><li>Oversee the general administrative functions of the office, handle administrative tasks including drafting correspondence, filing documents, and maintaining organizational systems.</li><li>Oversee the smooth operation of the corporate office, ensuring office supplies are stocked, equipment is maintained, and facilities are well-organized.&nbsp;</li><li>Ensure office operations run smoothly, maintaining a clean and well-organized workspace.</li><li>Help with ad-hoc tasks and projects as directed by the CXOs and corporate employees.</li><li>Serve as a liaison with building management vendor, external vendors, and service providers to address any office-related needs/issues.&nbsp;</li><li>Supervise office pantry and security staff</li></ul> Communication and Correspondence: <ul><li>Act as the primary point of contact between the CXOs and internal/external stakeholders.</li><li>Handle incoming and outgoing communications, including emails, phone calls, and mail.</li><li>Draft and proofread documents, reports, and presentations.</li><li>Draft and distribute internal and external communications, including announcements and reports for the CXOs</li><li>Coordinate and facilitate effective communication within the office.</li></ul> Requirements: <ul><li>5 years +&nbsp;</li><li>Global MNC experience is preferred.</li><li>Bachelors degree in business administration, management, or a related field (preferred).</li><li>Proven experience as both personal assistant and admin lead.</li><li>Excellent communication skills, both written and verbal, with the ability to interact professionally with individuals at all levels.</li><li>Strong attention to detail and accuracy in all work performed.</li><li>Strong organizational and multitasking abilities.</li><li>Arrange and coordinate office events, meetings, and conferences, including logistics and catering arrangements.</li><li>Understanding of 3rd Party Compliances.</li></ul>

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>

Responsibilities: Quote and Order Management: <ul><li>Interface with Customers for Quote request or Price inquiries and approval</li><li>Submit quotation request for pricing team approval.&nbsp;</li><li>Sales order entry, order confirmation &amp; expediting orders.</li><li>Order change and backlog price adjustment</li><li>On-going Backlog Management</li><li>Shipment release and follow up</li><li>Report and support past due backlog reduction</li><li>NPI - follow up with PM/Plant/Finance for part master and cost setup</li><li>Handle Sample order</li><li>Process RMA / Goods replacement</li></ul> Customer Service: <ul><li>Handle customer enquiries &amp; complaints. Investigate and work with other departments to resolve customer issues in a timely manner.&nbsp;</li><li>Emails/Conference calls / Customer and company Plant Visits for critical delivery issues, expedition or projects.&nbsp;</li><li>Work out solutions on Customer’s special requirements, such as label, Customs process, packing &amp; etc.&nbsp;</li><li>NPS/VOC/Customer Service Survey Improvement Process. Identify and work on corrective actions to recurring issues.&nbsp;</li></ul> Customer Supply Chain Management: <ul><li>Initiate Stock Requisition for customer advance order or buffer stock.</li><li>Work with Planning team on capacity adjustment in order to fulfill Customer’s demands</li><li>Consignment Stock Management/ Customer demand forecast monitoring and accuracy analysis</li><li>Manage customer forecast/demand and inventory level, work with Supply Chain to fulfill customer demand.&nbsp;</li><li>Negotiate with Customer for VMI liability and deadstock compensation.</li><li>Resolve logistics and custom issues with relevant functions</li></ul> Customer Credit and Billing Management: <ul><li>Billing attainment</li><li>Follow up queries with Account Receivable</li><li>Coordinate with Finance and Customer to solve pass due invoices issue</li><li>Manage customer credit status &amp; escalate for any abnormal status</li><li>Apply credit release</li><li>Process Credit note / Debit Note</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent</li><li>2–3+ years in customer service / order management (manufacturing preferred)</li><li>Strong communication and stakeholder management skills</li><li>Experience handling customer complaints and resolution</li><li>Ability to work under pressure in a fast-paced environment</li><li>Proactive mindset with strong ownership and accountability</li><li>SAP knowledge preferred</li><li>Mandarin communication capability is a plus</li></ul>

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: Process Documentation and Modelling: <ul><li>Collaborate with business stakeholders and process owners to understand and document existing processes using BPMN notation.</li><li>Create detailed process maps, workflows, and diagrams that accurately represent the end-to-end processes and related activities (process map should include clear RACI, Tools, WI)</li><li>Ensure that all process documentation is clear, consistent, and follows best practices in BPMN modelling.</li><li>Adopt Single Source of Truth concept, utilize BPMN-tool to create, update, and maintain process documentation in a centralized and accessible manner.</li><li>Ensure process KPI are define &amp; documented</li></ul> Process Analysis and Optimization: <ul><li>Work with process owner to analyse processes &amp; identify inefficiencies, bottlenecks, and areas for improvement.</li><li>Work with process owner &amp; cross-functional teams to propose for process optimizations and enhancements using BPMN-tool capabilities.</li><li>Validate process changes with stakeholders and ensure that process improvements align with organizational goals, including handshake process to cross functional team</li><li>Ability to perform data analysis with big data and summarize into actionable insight</li></ul> System Knowledge &amp; Analysis: <ul><li>Understand D365 system logic &amp; guide users to follow the documented purchasing processes &amp; principles during day-to-day operation</li><li>Able to drill through system data &amp; perform analysis per business request using available analytic tools (PowerBI, Excel, Power Apps, etc)&nbsp;</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Management, Purchasing or a related field. Masters degree is a plus.</li><li>Proven experience (typically 5+ years) in business process management, process documentation, or related roles.</li><li>At least 3 years working experience in operational supply chain functions (mainly focus on purchasing)</li><li>Excellent project management skills, planning, prioritization, ability to innovate and execute on solutions that matter, and provide timely updates/recommendations.</li><li>Good analytical, influencing and problem-solving skills and ability to handle team and client discussions.</li><li>Flexible to take on ad-hoc assignment or project as necessary.</li><li>Logical &amp; Analytical mindset with the ability to identify process improvement opportunities through data analysis.</li><li>Excellent communication skills, both written and verbal, to effectively collaborate with stakeholders and present complex concepts.</li><li>Understanding of process improvement methodologies such as Lean, Six Sigma, or Business Process Reengineering (BPR).</li><li>Familiarity with compliance and regulatory requirements related to business processes.</li><li>Experience with stakeholder management with strong influencing skillset</li></ul>

Responsibilities: Process Documentation and Modelling: <ul><li>Collaborate with business stakeholders and process owners to understand and document existing processes using BPMN notation.</li><li>Create detailed process maps, workflows, and diagrams that accurately represent the end-to-end processes and related activities (process map should include clear RACI, Tools, WI)</li><li>Ensure that all process documentation is clear, consistent, and follows best practices in BPMN modelling.</li><li>Adopt Single Source of Truth concept, utilize BPMN-tool to create, update, and maintain process documentation in a centralized and accessible manner.</li><li>Ensure process KPI are documented</li></ul> Process Analysis and Optimization: <ul><li>Work with process owner to analyse processes &amp; identify inefficiencies, bottlenecks, and areas for improvement.</li><li>Work with process owner &amp; cross-functional teams to propose for process optimizations and enhancements using BPMN-tool capabilities.</li><li>Validate process changes with stakeholders and ensure that process improvements align with organizational goals, including handshake process to cross functional team</li></ul> System Knowledge &amp; Analysis: <ul><li>Understand D365 system logic &amp; guide users to follow the documented planning processes &amp; principles during day-to-day operation</li><li>Able to drill through system data &amp; perform analysis per business request using available analytic tools</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Management, Information Technology, Warehouse/Logistic or a related field. Masters degree is a plus.</li><li>Proven experience (typically 5+ years) in business process management, process documentation, or related roles.</li><li>At least 3 years working experience in operational supply chain functions (Warehouse/Logistic)</li><li>Excellent project management skills, planning, prioritization, ability to innovate and execute on solutions that matter, and provide timely updates/recommendations.</li><li>Good analytical, influencing and problem-solving skills and ability to handle team and client discussions.</li><li>Flexible to take on ad-hoc assignment or project as necessary.</li><li>Logical &amp; Analytical mindset with the ability to identify process improvement opportunities through data analysis.</li><li>Excellent communication skills, both written and verbal, to effectively collaborate with stakeholders and present complex concepts.</li><li>Understanding of process improvement methodologies such as Lean, Six Sigma, or Business Process Reengineering (BPR).</li><li>Familiarity with compliance and regulatory requirements related to business processes.</li></ul>

Responsibilities: <ul><li>Select the desired employees and develop, implement, and monitor the programs and processes used in recruitment and selection.&nbsp;</li><li>They source, recruit, screen, interview and recommend external and/or internal candidates to staff open requisitions.&nbsp;</li><li>Utilize the services of employment agencies and/or place employment ads in appropriate sources, including the intranet, Internet, and print media.&nbsp;</li><li>Responsible for developing and implementing recruiting plans and administering talent management efforts and employee referral programs, managing the resume tracking system and ensuring consistent corporate image throughout recruiting campaigns.&nbsp;</li><li>Lead end-to-end recruitment, ensuring alignment with organizational strategy and culture.</li><li>Manage end-to-end hiring process: Source, resume screen, phone screen, schedule interviews, Offer documentation and onboarding</li></ul> Requirements: <ul><li>Minimum 6+ years of experience required for this role.</li><li>Should possess expert knowledge and innovative skills to source and attract active &amp; passive talent from different sourcing channels (job boards, social media, referrals and local outreach to identify potential candidates</li><li>Communication and Stakeholder management is key to be successful in this role as you work with global stakeholders and matrix organization</li><li>Good understanding of the engineering manufacturing industries in the local market, able to map talents, develop business intelligence for sourcing strategies and techniques</li></ul> Qualification <ul><li>Experience in handling end-to-end Talent Attraction Process [Source to Onboard]</li><li>Be able to develop Recruiting Strategies basis the skill demand and complexities</li><li>Expert knowledge and Hands-on in preparing market research, Market/Talent mapping using various tools such as Talent Neuron, Draup, LinkedIn Talent Insight</li><li>Data driven: able to analyse, slice &amp; dice data, develop insights from data and be able to make decisions to drive hiring strategies</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>Perform bank reconciliation to protect the organizations assets and verify the accuracy of cash transactions.</li><li>Reconcile and analyze balance sheet accounts, ensuring accuracy through vouching for source details and resolving discrepancies.</li><li>Generate reports and perform account analysis to resolve mis-recordings before the finalization of financial statements.</li><li>Collaborate with various partners for critical financial deliverables and maintain an audit trail of supporting documents.</li><li>Handle Fixed Asset Accounting, including asset recognition, depreciation, transfer, retirement, and write-off.</li><li>Ensure compliance with internal controls and Generally Accepted Accounting Principles (GAAP), as well as Corporate Policies and Procedures (CP&amp;P). Decisions are made through standard operating procedure.</li></ul> Requirements: <ul><li>4-5 Years of Exp.&nbsp;</li><li>BS Accountancy or Any Finance Course with Accounting Knowledge</li><li>Advanced knowledge and understanding of job specific tasks and procedures, with the ability to analysze and solve complex problems independently.</li><li>Requires advanced problem solving skills and can handle complex issues independently</li><li>Skills manifested consistently in pushing limits, voluntarily stepping in without hesitation in a situation that requires assistance or even does not have complete knowledge of the situation.&nbsp;</li><li>Performs highly complex tasks and develops innovative solutions to solve problems.&nbsp;</li><li>Works autonomously, making independent decisions and taking responsibility for outcomes</li><li>Builds and maintains relationships with key stakeholders, both internal and external, and effectively communicates complext information.&nbsp;</li><li>Significant leadership experience is observed thru effective buddy system, acting as an SME, thru project involvement and stretch assignments in handling people management in a small scale responsibility.&nbsp;</li><li>Follows business practices, process and procedures. </li><li>Expected to suggest ideas to improve ways of working, quick understanding of the business and easy to provide business solutions.&nbsp;</li><li>Can assess impact of decision to the business and process.&nbsp;</li><li>Can easily communicate across level of organization without difficulty. Can able to express clearly thoughts and opinion and does challenge the status quo.&nbsp;</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>

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75 corporate functions Jobs found

Executive Assistant and Administrative Lead

Sr. Manager, Quality & Reliability Engineering

Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

TA Specialist

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

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75 corporate functions Jobs found

Executive Assistant and Administrative Lead

Sr. Manager, Quality & Reliability Engineering

Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

TA Specialist

Site Quality Leader

General Ledger Specialist

Associate Director RA & QA

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

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