About ApotexApotex is a Canadian-based global health company improving access to affordable, innovative medicines and health products worldwide. Headquartered in Toronto with regional offices globally, it is the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas.Job SummaryThe Associate Director, Quality Operations is a senior member of the Quality Team responsible for continuously improving overall Quality Operations at the Apotex Richmond Hill manufacturing site. Reporting to the Senior Director, Quality, the role oversees Material and Product Disposition, Quality Investigations, Quality Assessment, Quality Management System Records, the Controlled Substances Program, and compliance escalations and regulatory reporting of critical events.Job ResponsibilitiesOverall responsible for Quality activities supporting regulatory compliance and business requirements at the manufacturing site:Provide visible, results‑oriented leadership supporting Apotex’s Mission, Core Values and strategic plan.Implement internal quality procedures ensuring adherence to Global Quality Policies, Standard Operating Procedures and GMPs.Establish and maintain Quality performance metrics that support corporate and site‑specific quality goals.Be an active member of the Quality Management team and support a team environment within all segments of Quality.Represent Apotex position and policy during regulatory/customer audits.Participate actively in Quality forums and drive actions to remediate compliance risks.Support best‑practice sharing, harmonization,



standardization and continuous improvement across the Apotex organization.Lead the department by maintaining a sustainable Quality Culture and collaborating cross‑functionally within the Site Quality Organization for alignment and consistent messaging.Oversee Investigations Management, ensuring site quality investigations are handled compliantly and efficiently.Accountable for overall QA Material/Product Disposition activities, documentation and support for logistics, distribution and warehouse activities.Oversee quality approval of QA management system records, ensuring skilled resources provide appropriate quality approvals.Responsible for compliance escalations and regulatory reporting of critical events and recall process at the site.Oversee the Controlled Substances Program at the site and continuously improve GMP activities.Develop and maintain knowledge of GMP requirements for non‑sterile, sterile and controlled‑substance products.Participate and lead performance conversations with employees, providing support and removing barriers.Utilize open, honest, two‑way communication to build trust‑based relationships.Job RequirementsEducation:



Bachelor of Science DegreeKnowledge, Skills & Abilities:Robust understanding of GMP requirements in sterile and non‑sterile production and controlled substances.Strong organizational, interpersonal and communication skills.Business acumen in cross‑functional processes and relevant information flows.Strategic, process‑driven, analytical and critical thinking.Experience holding people accountable, developing teams and facilitating decision‑making.Ability to lead, manage and motivate subordinates.Relationship management and networking skills.Ability to deal with ambiguity and manage multiple, complex projects.Strong written and oral communication.Experience:Minimum 10 years of quality assurance experience in the pharmaceutical industry.Minimum 7 years of leadership and people management experience in a quality role.Experience in sterile and non‑sterile pharmaceutical production operations, investigations, CAPAs, Change Control, Material Release, Batch Release and Controlled Substances.Compensation and BenefitsThe hiring range is $126,425.43–$176,425.43 CAD per year, with potential adjustments based on experience. Apotex offers a comprehensive benefits package including a pension plan, learning and development opportunities, and bonus programs.Equal Employment OpportunityApotex is committed to fostering a welcoming and accessible work environment where everyone feels valued and respected. The company provides accommodation for applicants with disabilities.#J-18808-Ljbffr

📌 Associate Director, Quality Operations - C$126,425.4 - C$176,425.4 A Year (Winnipeg)
🏢 APOTEX
📍 Winnipeg