Vice President of Sterility Assurance at GSK, leading sterility strategy across Engineering, QA, and MSAT. Driving compliance and implementing robust risk controls in regulated environments.
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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