Manager, R&D QA Liquid Dose

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit:

The Manager, R&D QA Liquid Dose is responsible for developing and maintaining a focused team, skilled and trained to support the compliance and business needs of R&D manufacturing, packaging and laboratory operations in support of New Product Development at Richmond Hill. Overall responsibilities include the disposition decisions made on R&D semi‑finished and packaged materials, review and approval of experimental batch manufacturing documents, supervising and training staff, preparing and responding to audits, point of contact for local quality issues, ensuring investigation and deviations are handled in a compliant manner with pre‑defined timelines, and working with the Associate Director, CMC QA to develop programs for ensuring the continuous improvement in the quality of operations in Product Development.

• Manages the on-going QA activities which support the 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 R&D Project Management to determine scheduled activities and changes to the manufacturing schedule.
• Oversees assignment of work to direct reports for the review and approval of R&D manufacturing/packaging masters and executed manufacturing/packaging batch documents, as well as the review and approval of R&D specifications, test results, release of experimental raw materials (API, excipients and packaging components) and non-commercial finished product batches (such as IMPs and submission batches).
• 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 (such as IMPs and submission batches).
• Review and approve documents required for regulatory submissions.
• Review, coordinate and approve activities for deviation investigations and CAPA for experimental materials and manufacturing of non-commercial batches. These include the complaint investigations for IMPs.
• Supports change through review and approval of change control requests for master manufacturing/packaging documents, analytical methods, specification, SAP material code creations, SAP Master Data, Standard Operating Procedures (SOPs) and other controlled documents.
• Ensure implementation of appropriate processes and continuous improvement initiatives in order 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.
• Serve as primary contact and consultant for quality issues pertaining to R&D operations.
• In conjunction with the Associate Director, CMC QA, conducts appropriate resource planning analysis for headcount forecast.
• Participate and lead performance conversations with employees, check in on employee’s progress toward achieving Objectives, offer support and…