Sterility Assurance Excellence Lead – Senior Director
GSK
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • United States
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Salary
💰 $207,075 - $345,125 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
- Excellent communication, governance, and stakeholder management skills
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus and eligibility to participate in our share based long term incentive program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
sterility assurancecontamination controlcleaning validationprocess controlsupplier qualificationQMS integrationdeviation managementinspection readinessregulatory compliancefacility design
Soft Skills
leadershipcross-functional collaborationcommunicationgovernancestakeholder managementrisk mitigationstrategic decision-makingcapability building