Vice President – Sterility Assurance
GSK
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • United States
Visit company websiteExplore more
Salary
💰 $225,000 - $375,000 per year
Job Level
About the role
- 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)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
sterility assurancecleaning validationprocess controlsupplier qualificationQMS integrationdeviation managementinspection readiness
Soft Skills
leadershipcross-functional alignmentrisk mitigationstrategic decision making