Role Summary
You will lead standards and compliance for sterile manufacturing at a GSK UK site. You will work closely with operations, quality, engineering, and supply teams to ensure safe, compliant, and reliable sterile production. This role will provide the opportunity to lead key activities to progress your career.
Responsibilities
- Define, maintain and continuously improve sterile operational standards, ensuring alignment with regulatory requirements and site/global expectations.
- Drive consistency across manufacturing areas through standard work, ownership of the management monitoring universe, and standardisation of procedures, batch documentation and operational practices.
- Establish and maintain governance processes to ensure standards are deployed, understood, consistently applied and reflected in audit and inspection readiness activities.
- Identify gaps, deviations, and variability in ways of working, leading improvements and corrective actions to strengthen control, compliance and operational performance.
- Monitor adherence to standards through data review, audits and performance indicators, escalating risks and supporting governance forums where required.
- Coach operational teams and leaders on standards execution, working with Quality, Engineering, Sterility Assurance and Operations to ensure standards evolve with process or equipment changes.
Basic Qualifications
- Experience in sterile pharmaceutical manufacturing or sterile aseptic processes in a regulated environment.
- Solid understanding of Good Manufacturing Practice (GMP) for sterile products and contamination control principles.
- Practical experience managing deviations, investigations and CAPA (corrective and preventive actions).
- Experience supporting audits and regulatory inspections as part of sterile operations.
- Strong interpersonal skills with experience coaching or guiding production and technical teams.
- Experience with cleanroom classifications, environmental monitoring and sterility assurance methods.
Preferred Qualifications
- Degree or formal qualification in pharmacy, life sciences, engineering or a related discipline.
- Knowledge of aseptic process validation, sterilisation methods and media‑fill activities.
- Experience with manufacturing systems such as MES, SAP or electronic batch records.
- Training or experience in continuous improvement methods such as Lean or Six Sigma.
- Previous role as Steriles Standards lead, Steriles Manager, or similar within pharmaceutical manufacturing.
Working Model
This role is on‑site at Barnard Castle. You should be prepared to spend significant time at the manufacturing site to lead activities and work directly with operational teams.
Equal Opportunity Employer
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.
