Sterility Assurance Excellence Lead (Senior Director)

Sterility Assurance Excellence Lead (Senior Director)

Our global supply chain is critical to manufacturing and supplying reliable, high‑quality medicines and vaccines to meet patients' needs and drive our performance. It includes 37 medicines and vaccines manufacturing sites that positively impact the health of millions of people. Supply chain teams are part of how we prevent and change the course of disease, bringing our innovations to patients as quickly, efficiently and effectively as possible. They are involved early in product and process development, working with R&D to make sure that what works in clinical trials can be scaled up to commercial production. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We use data to monitor production in real time, spot ways to increase yields and predict when equipment needs maintenance. Smart manufacturing technologies give greater efficiency, productivity, sustainability and cost savings. By augmenting human creativity and expertise with data and AI, we deliver better and faster for patients.

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 standardised 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 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 standardised 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.

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.

Location and Compensation

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

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $207,075 to $345,125.
• The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role.
• In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program which is dependent on the level of the role.
• Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Equal Opportunity Statement

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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