Lead, Sterility Assurance

Job Summary The Sterility Assurance Lead is accountable for maintaining a sustained state of sterility assurance at the Richmond Hill site, and serves as the site technical authority for the contamination control strategy and aseptic processing operations. This role is responsible for ensuring regulatory inspection readiness, owning the Contamination Control Strategy lifecycle, governing sterility‑impacting changes, and ensuring alignment with Annex 1 and global regulatory expectations. The role involves managing daily operations, driving continuous improvement initiatives, sterility assurance related investigations, and providing expert technical support to ensure compliance with corporate and site sterility assurance standards. The Sterility Assurance Lead partners closely with Quality, Manufacturing, Engineering, Validation and other cross‑functional teams to embed sterility assurance principles into day‑to‑day operations, change management, and long‑term site strategy.

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