Vice President, Sterility Assurance overseeing sterility strategy and compliance at GSK. Driving cross-functional alignment and risk mitigation for quality and regulatory standards.
Responsibilities
Own and deploy sterility assurance strategy, standards, and governance to ensure compliance to regulatory expectations.
Lead cross-functional alignment and risk mitigation across Engineering, QA, and MSAT.
Ensure contamination control strategy is standardized and embedded in QMS.
Oversight of facility design and equipment reliability aligned with sterility assurance requirements.
Lead cleaning validation, process control, and supplier qualification as it relates to sterility assurance standards.
Ensure QMS integration, deviation management, and inspection readiness.
Chair monthly governance forums and drive strategic decisions.
Build capability through Communities of Practice.
Requirements
Bachelor’s degree in microbiology, life sciences, engineering, or related field, or equivalent experience.
Significant experience in sterility assurance, microbiology, or quality in a regulated manufacturing environment.
Proven leadership in cross-functional roles including QA, Engineering, and MSAT.
Strong knowledge of Annex 1, GMP, and global regulatory requirements.
Experience in inspection readiness
Benefits
health care and other insurance benefits (for employee and family)
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