Head of Sterility Assurance and Contamination Control
Introduction to role:
Are you ready to set the global standard for sterility assurance and contamination control so patients receive safe medicines without interruption? In this senior leadership role, you will shape how sterility assurance is practised across a worldwide network producing therapies for people with rare diseases, safeguarding both patient safety and reliable supply.
You will own the global strategy for sterility assurance and contamination control, harmonizing standards and elevating technical excellence across Drug Substance, Drug Product and Combination Product manufacturing at internal sites and CDMOs. Reporting to the Executive Director of Technical Operations, you will embed sterility assurance within the Pharmaceutical Quality System, strengthen oversight of microbial and aseptic risks, and ensure data-driven, inspection-ready systems that stand up to the toughest scrutiny. Will you turn data into foresight, transforming environmental monitoring signals and deviation trends into proactive prevention?
As a strategic partner to QA, QC and Site Quality leaders, you will guide site-based microbiologists and aseptic processing specialists through a matrixed governance model—building capability, enabling independent quality decisions, and fostering a culture where scientific rigor and speaking up drive continuous improvement.
Accountabilities:
\- Global SA&CC Strategy and Standards: Set and own the global sterility assurance and contamination control strategy, harmonized standards and technical positions; ensure consistent application and measurable outcomes across the network.
\- Contamination Control Strategy (Annex 1): Define the technical content and structure for integrated, science- and risk-based CCS documents; jointly review and approve site CCS with QA, keep them current and compliant, and verify effectiveness via periodic reviews.
\- Aseptic Processing Technical Excellence: Establish network standards for aseptic design and operation, including cleaning and disinfection, sporicidal programs, cleanroom design and qualification, EM programs, gowning and personnel qualification, material and equipment transfer, and sterilization validation; provide input on HVAC, utilities and facility design.
\- Aseptic Process Simulation (Media Fills): Own the global APS strategy and technical standards to ensure simulations provide robust proof of control and continued aseptic capability.
\- Contamination Event Res...
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