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 SummaryThe Associate Director of Manufacturing Quality is a strategic leader responsible and accountable for quality assurance activities across sterile and non-sterile manufacturing operations. This role leads the manufacturing quality team, ensures compliance with global regulatory standards, drives continuous improvement, and fosters a culture of quality excellence. The Associate Director partners cross‑functionally to ensure quality is embedded in all aspects of manufacturing and packaging.Job ResponsibilitiesProvide on the floor quality support and oversight for manufacturing operations, including aseptic processing, and non‑sterile production.Provide technical and regulatory guidance/direction to QAIP team pertinent to regulatory compliance.Manage and mentor QAIP team, providing quality oversight of sterile and non‑sterile manufacturing related activities.Ensure timely review and approval of batch records, deviations, CAPAs, and change controls.Responsible for the management of retain samples, including oversight of the governing program and ensuring compliance with applicable regulatory and internal quality requirements.Monitor quality metrics and trends to proactively address risks and opportunities.Lead preparation and response efforts for regulatory inspections and internal audits.Maintain awareness and current knowledge of evolving regulatory expectations, GMP trends and industry standards associated with quality and compliance.Partner with Manufacturing, Engineering, Validation to ensure quality is integrated into all processes.Support technology transfers, new product introductions,



and process improvements.Support sterility validation team and sterility assurance group as needed and provide recommendations into the validation activities.Identify, drive and implement continuous improvement initiatives to enhance efficiency and reduce operational bottlenecks while ensuring quality and compliance are always maintained.Develop departmental budget plans and headcount projections. Track and manage budget.Ensure compliance of team members with safety and employment policies.Perform all work in accordance with corporate quality policies and programs and all established regulatory and safety requirements.Uphold high ethical standards and ensure compliance with ethical guidelines.Foster a culture of integrity and accountability within the team.Recruit, mentor and develop a high‑performing team, while fostering a positive and collaborative work environment.Utilize open, honest, two‑way communication to build trust‑based relationships with employees, business partners and direct leaders while continuously improving leadership capabilities by personally seeking feedback and development.Create a culture which values trust and provides the opportunity for employee development and growth in pursuit of our purpose and demonstrating our core values – integrity, teamwork, courage and innovation.Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard newemployees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.Ensure adherence of team members (direct reports)



with all compliance programs and company policies and procedures.All other duties as assigned.Job RequirementsEducationUniversity degree in a science discipline.Knowledge, Skills and AbilitiesDeep understanding of Health Canada, USFDA, EMA, ICH, and other global regulatory requirements.Ability to lead, manage and motivate others.Strong organizational, interpersonal and communication skills.Strong analytical, decision‑making and communication skills.Experience with quality risk management (QRM), root cause analysis.Proficiency in electronic quality systems (e.G., TrackWise) and Microsoft Office tools.Ability to influence across levels and functions in a matrixed organization.ExperienceMinimum 7 years’ experience in the pharmaceutical industry with at least 5 years of experience in sterile operations.Minimum 2 years of sterile, quality oversight experience would be an asset.Proven leadership experience in a GMP‑regulated environment.At Apotex, we are committed to fostering a welcoming and accessible work setting, where 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.The hiring range for this position is $126,425.43 - $176,425.43 CAD per year. The final agreed‑upon salary may vary based on factors such as job‑related knowledge, skills and experience.We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed‑upon salary may be adjusted to reflect your individual qualifications.The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay‑for‑performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.Apotex will use artificial intelligence to screen, select and/or assess your application for this job.This job posting is for a role that is currently available and vacant at Apotex.#J-18808-Ljbffr

📌 Associate Director, Mfg Quality-Gqc-Qcr R - C$126,425.4 - C$176,425.4 A Year (Toronto)
🏢 APOTEX
📍 Toronto