Vice President Sterility Assurance

Role Summary

Vice President, Sterility Assurance. Provide leadership in shaping and delivering a global sterility strategy across Engineering, QA, Business Units and MSAT. Drive standardisation, implement robust risk controls, and ensure inspection readiness across GSK’s network and end-to-end business processes, positively impacting quality and compliance.

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.

Strategic Objectives

• Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites
• Set vision for the future 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 clear project and governance frameworks to clarify roles and responsibilities between global and local teams
• Drive continuous improvement and proactive inspection readiness
• Lead the uplift in capability building and leadership development across functions
• External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology

Qualifications

• Bachelor‚Äôs 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

Education

• Preferred: Advanced degree in microbiology, pharmaceutical sciences, or engineering.

Additional Requirements

• This role can be based at one of our manufacturing sites in the US (East coast), Europe or UK.