Description

<p><b>About the Job</b></p><p>A global pharmaceutical CDMO/CMO facility in Montréal area is seeking a Senior Director of Quality to lead all site quality activities. The site manufactures sterile injectables (including lyophilized products), ophthalmic/otic products, and non‑sterile dosage forms (creams, ointments, gels, liquids) for multiple international clients.</p><p><br></p><p><b>Key Responsibilities</b></p><ul><li>Lead site Quality Assurance, Quality Control, and Quality Systems for a high‑volume CDMO/CMO facility.</li><li>Ensure full GMP compliance with Health Canada, FDA, EMA and applicable ICH/Annex 1 requirements for sterile and non‑sterile manufacturing.</li><li>Own and strengthen the Quality Management System (deviations, CAPA, change control, complaints, investigations, data integrity).</li><li>Serve as final quality decision‑maker for batch disposition and major quality risk decisions.</li><li>Prepare for and lead Health Authority inspections and client audits, including responses and follow‑up actions.</li><li>Provide quality oversight for aseptic filling, lyophilization, ophthalmic manufacturing, environmental monitoring, and sterility assurance.</li><li>Partner with Operations, Technical Services, and Regulatory to support tech transfers, process validation, and reliable commercial supply.</li><li>Lead, coach, and develop a multi‑disciplinary quality team and foster a strong quality culture.</li></ul><p><br></p><p><b>Qualifications</b></p><ul><li>Bachelor’s degree in a scientific discipline required; advanced degree an asset.</li><li>12+ years of pharmaceutical Quality experience, with substantial time in sterile/aseptic manufacturing (injectables and/or ophthalmic) and at least 5+ years in senior site leadership (Director level or above).</li><li>Experience in a CDMO/CMO or multi‑client commercial manufacturing environment strongly preferred.</li><li>Proven success hosting Health Authority inspections and complex client audits.</li><li>Deep knowledge of GMP, Annex 1, sterility assurance, and data integrity requirements.</li><li>Strong leadership, stakeholder management, and communication skills; English required, French highly preferred.</li></ul><p><br></p><p>To explore this confidential opportunity, please submit your CV and a brief note summarizing your sterile manufacturing and inspection experience.</p>