Senior Director Quality - Montreal (administrative region) - Barrington James

    Barrington James
    Barrington James Montreal (administrative region)

    1 week ago

    Description

    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.

    Key Responsibilities

    • Lead site Quality Assurance, Quality Control, and Quality Systems for a high‑volume CDMO/CMO facility.
    • Ensure full GMP compliance with Health Canada, FDA, EMA and applicable ICH/Annex 1 requirements for sterile and non‑sterile manufacturing.
    • Own and strengthen the Quality Management System (deviations, CAPA, change control, complaints, investigations, data integrity).
    • Serve as final quality decision‑maker for batch disposition and major quality risk decisions.
    • Prepare for and lead Health Authority inspections and client audits, including responses and follow‑up actions.
    • Provide quality oversight for aseptic filling, lyophilization, ophthalmic manufacturing, environmental monitoring, and sterility assurance.
    • Partner with Operations, Technical Services, and Regulatory to support tech transfers, process validation, and reliable commercial supply.
    • Lead, coach, and develop a multi‑disciplinary quality team and foster a strong quality culture.

    Qualifications

    • Bachelor's degree in a scientific discipline required; advanced degree an asset.
    • 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).
    • Experience in a CDMO/CMO or multi‑client commercial manufacturing environment strongly preferred.
    • Proven success hosting Health Authority inspections and complex client audits.
    • Deep knowledge of GMP, Annex 1, sterility assurance, and data integrity requirements.
    • Strong leadership, stakeholder management, and communication skills; English required, French highly preferred.

    To explore this confidential opportunity, please submit your CV and a brief note summarizing your sterile manufacturing and inspection experience.


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