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: www.apotex.com.

Job Summary

The Manager, Sterility Assurance oversees the comprehensive lifecycle of contamination control and sterile validation programs at the Richmond Hill site. This role involves managing daily operations, driving continuous improvement initiatives, and providing expert technical support to ensure compliance with corporate and site sterility assurance standards.

Job Responsibilities Responsible for overall management of the contamination control program, including but not limited to the following: Aseptic Process Simulations (Media Fill) Aseptic Operator Qualification Program Sterility Assurance and Contamination Control Training Programs Environmental Montioring and Clean Utilities Monitoring Programs Cleaning and Disinfection Program Overall management of the sterile validation program to ensure all validation activities and conducted and maintained in accordance with corporate policies and regulatory requirements, including but not limited to the following: Thermal (Moist / Dry Heat) and Gaseous (VHP / ETO) Validation Irradiation (Gamma / E-Beam) of Primary Packaging Components Container Closure Integrity Sterilizing Filter Validation Airflow Visualization Studies (Smoke Studies) Provide technical guidance and subject matter expertise to sterile and non-sterile production operations Responsible for providing guidance for investigations related to sterile operations, environmental monitoring, clean utilities and contamination control programs and ensuring appropriate CAPAs are established and implemented Provide quality direction and technical guidance to engineering projects for sterility assurance Work cross-functionally to develop contamination control technical expertise and communicate associated vision and objectives in alignment with Apotex’s strategic business objectives. Support business planning processes and champion initiatives to identify future business needs and opportunities through regular communication with internal stakeholders.Represent Apotex to regulatory agencies and industry groups in order to develop and influence industry standards with respect to overall Operation processes and procedures. Be an active member of the Quality Leadership Team and help support a team environment within all segments of the company. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development. Cultivate a culture that values trust and promotes employee development and growth, aligned with the company’s winning behaviors of Individual Accountability, Rigor & Descipline and Continuous Improvement. Attract and hire talent through comprehensive and consistent recruitment processes, ensuring a positive onboarding experience. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures. Perform other duties as assigned. Job Requirements Education Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering or related discipline. Knowledge, Skills and Abilities Working knowledge of sterilzation validation, aseptic manufacturing, environmental monitoring, clean utilities, contamination control and microbiology. Strong technical writing, oral and written communication skills. Comprehensive understanding of current and evolving regulatory requirements (FDA, EU, ICH, ISO, Annex 1). Demonstrated ability to instil a culture of high performance, accountability and quality. Demonstrated communication, interpersonal and relationship management skills. Strong ability to deal with ambiguity and manage through difficult situations. Excellent ability to delegate and can effect change through others without direct involvement. Exercises innovative tactics and encourages others to demonstrate creative approaches. Experience with US FDA and Health Canada (or equivalent) regulatory inspections.

Experience Minimum 7-10 years of experience in a GMP production environment, sterile manufacturing experience is an asset. Minimum 3+ years in a leadership role, preferably in the pharmaceutical or equivalent industry

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.