Sterility Assurance Excellence Lead (Senior Director)
GSK
10 hours ago
On-site
Waltham, MA
Operations
Sterility Assurance Excellence Lead (Senior Director)
Key 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.
- Oversee 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.
Strategic Objectives
- Accountable for transformation of sterility assurance global standards across Engineering, MSAT, and Quality for use across all sites.
- Set vision to proactively meet regulatory expectations.
- Accountable for program management for execution/implementation to global standards.
- Deliver Annex 1 compliance through standardized global policies.
- Implement KPI dashboards for contamination control and cleaning validation.
- Define project and governance frameworks clarifying roles between global and local teams.
- Drive continuous improvement and proactive inspection readiness.
- Lead capability building and leadership development across functions.
- External network/advocacy with industry forums and regulators.
Basic Qualifications
- 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.
Preferred Qualifications
- Advanced degree in microbiology, pharmaceutical sciences, or engineering.
Key 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.
- Oversee 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.
Strategic Objectives
- Accountable for transformation of sterility assurance global standards across Engineering, MSAT, and Quality for use across all sites.
- Set vision to proactively meet regulatory expectations.
- Accountable for program management for execution/implementation to global standards.
- Deliver Annex 1 compliance through standardized global policies.
- Implement KPI dashboards for contamination control and cleaning validation.
- Define project and governance frameworks clarifying roles between global and local teams.
- Drive continuous improvement and proactive inspection readiness.
- Lead capability building and leadership development across functions.
- External network/advocacy with industry forums and regulators.
Basic Qualifications
- 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.
Preferred Qualifications
- Advanced degree in microbiology, pharmaceutical sciences, or engineering.