Sterility Assurance Excellence Lead (Senior Director)
GSK
4 hours ago
On-site
Philadelphia, PA
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 the 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
- Transform sterility assurance global standards across Engineering, MSAT, and Quality; ensure use across all sites.
- Set vision to proactively meet regulatory expectations.
- Accountable for program management and 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 global vs. local roles and responsibilities.
- Drive continuous improvement and proactive inspection readiness.
- Lead uplift in capability building and leadership development across functions.
- External network/advocacy with industry forums and regulators.
Basic Qualifications (Required)
- 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 (QA, Engineering, 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.
Benefits (explicitly stated)
- Annual bonus; eligibility for share-based long-term incentive program.
- Health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Application/Recruitment Instructions
- For salary/benefits location specifics (non-US), compensation discussed during the recruitment process.
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 the 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
- Transform sterility assurance global standards across Engineering, MSAT, and Quality; ensure use across all sites.
- Set vision to proactively meet regulatory expectations.
- Accountable for program management and 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 global vs. local roles and responsibilities.
- Drive continuous improvement and proactive inspection readiness.
- Lead uplift in capability building and leadership development across functions.
- External network/advocacy with industry forums and regulators.
Basic Qualifications (Required)
- 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 (QA, Engineering, 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.
Benefits (explicitly stated)
- Annual bonus; eligibility for share-based long-term incentive program.
- Health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Application/Recruitment Instructions
- For salary/benefits location specifics (non-US), compensation discussed during the recruitment process.