Job Description
Associate Director, Sterility Assurance
Blackfield Associates are proud to be supporting a leading biopharmaceutical organisation in the search for an experienced Sterility Assurance professional to join their organisation as a Senior Manager / Associate Director.
This position plays a critical role in ensuring the integrity of aseptic manufacturing operations by leading sterility assurance and contamination control activities across GMP environments.
The Role
As the Associate Director of Sterility Assurance, you will:
1. Lead microbiological investigations into sterility failures, contamination events, and environmental monitoring (EM) excursions.
2. Act as the Subject Matter Expert (SME) for microbiological deviations, providing scientific rationale and ensuring robust root cause analysis and CAPA implementation.
3. Collaborate with QA, QC, Manufacturing, Validation, and Engineering to strengthen site-wide contamination control and continuous improvement initiatives.
4. Represent sterility assurance during internal and external audits and inspections.
5. Support and enhance the site’s contamination control strategy, including microbial risk assessments, trending, and preventive measures.
6. Provide technical le...