Manager, R&D QA Liquid Dose
5 days ago
Job Summary: Manager, R&D QA Liquid Dose responsible for leading a team to ensure compliance and business needs of R&D manufacturing, packaging, and laboratory operations.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations.
Job DescriptionThe Manager, R&D QA Liquid Dose is responsible for developing and maintaining a focused team to support the compliance and business needs of R&D manufacturing, packaging, and laboratory operations in support of New Product Development at Richmond Hill.
- Manages on-going QA activities to support business and GMP compliance needs of manufacturing, packaging, and laboratory operations in Product Development.
- Interacts with Richmond Hill R&D manufacturing/packaging groups, laboratories, and Global R&D Project Management to determine scheduled activities and changes to the manufacturing schedule.
- Oversees assignment of work to direct reports for review and approval of R&D manufacturing/packaging masters and executed manufacturing/packaging batch documents.
- Provides leadership and operational oversight for establishment of records and processes in support of 21 CFR Part 4 requirements for Combination Products.
- Reviews and approves Master Manufacturing/Packaging Masters and executed batch records for non-commercial materials.
- Oversees audit of data to release R&D raw materials, IMPs, and registration/submission batches.
- Reviews and approves Pharmaceutical Development Reports, analytical method validation protocols, and reports for R&D methods and other documents required for regulatory applications/submissions.
- Reviews, coordinates, and approves activities for deviation investigations and CAPA for experimental materials and manufacturing of non-commercial batches.
- Supports change through review and approval of change control requests for master manufacturing/packaging documents, analytical methods, specification, and other controlled documents.
- Ensures implementation of appropriate processes and continuous improvement initiatives to maintain effective quality standards in R&D.
- Provides assistance and leadership in preparation activities leading up to, during, and following regulatory or customer inspections.
- Provides support and management of the R&D self-inspection program at Richmond Hill.
- Serves as primary contact and consultant for quality issues pertaining to R&D operations.
- Conducts resource planning analysis for headcount forecast in conjunction with the Associate Director, CMC QA.
- Participates and leads performance conversations with employees, checks in on employee progress, offers support, and removes barriers.
- Creates a culture that values trust and provides opportunities for employee development and growth.
- Attracts and hires talent in a comprehensive and consistent manner.
- Ensures adherence of direct reports with all compliance programs and company policies and procedures.
- Education: B.Sc. in Chemistry, Microbiology, or related science.
- Knowledge, Skills, and Abilities:
- Thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D.
- Strong understanding of regulatory requirements for IMPs and registration batches.
- Excellent interpersonal skills with recognized leadership ability.
- Demonstrated ability to handle multiple work assignments.
- Experience with technical report writing/scientific documentation.
- Experience:
- Minimum six (6) years of QA experience in the pharmaceutical industry, three (3) years of supervisory experience, preferably in a QA role.
At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.
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