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Senior Audit Lead (EMEA GMP Audit)
GSK is hiring for the role of Senior Audit Lead (EMEA GMP Audit), Stevenage, UK (Hybrid). This is an Audit role in the governance, risk, and compliance field. Review the full details below and apply directly with GSK.
Are you an experienced Biopharm, Vaccines, or Pharmaceutical professional looking for an exciting opportunity to leverage your expertise to support GSK Senior Management in the identification, prioritisation, and monitoring of quality, compliance, and technical risks? If so, this role within our Quality organisation could be a great opportunity for you.
Position Details:
The purpose of the Audit Senior Lead role is to perform and manage GMP (Good Manufacturing Practice) and Compliance audits of Steriles, Biopharm, Vaccines, and Pharmaceutical facilities that supply highly regulated markets. You will be responsible for evaluating the compliance of GSK Global Supply Chain (internal and external) facilities with GMP, applicable policies and procedures, and regulatory and contractual commitments. Your remit will include audits of (Global Supply chain internal and external networks) manufacturing facilities and operations, Local Operating Companies (LOCs), R&D and Logistics Service Providers (LSPs).
In this role, you will also provide sterile manufacturing subject matter expertise for the GSK Global Supply Chain EMEA auditing team.
Please Note: Strong knowledge / experience of sterile, vaccines and / or biopharm manufacturing processes (alongside communication and influencing skills) are considered essential for delivering in this role.
Key Responsibilities include:
More experienced staff may undertake:
- Manage complex stakeholder engagement for audits across the network (which may include Supply Chain Directors, Site Directors, Site Quality Directors, VPs/Heads of support functions, and Research & Development Quality).
Typical work output will involve:
- Performing audits of Global Supply Chain (GSC) sites, LOCs, and external manufacturing sites (including R&D), LSPs and facilities supplying EMEA and other highly regulated markets.
- Preforming Unannounced audits.
- Preforming for-cause audits based on regulatory actions or identified risk.
- Preforming process, quality system-specific, and targeted audits.
- Performing audits against risk mitigation plans or regulatory citation commitments.
- As an output, it is critical to produce clear, concise, and accurate audit reports to ensure senior management is appraised of identified risks and that appropriate corrective action plans are implemented.
Location: This role can be based at any of the following manufacturing sites: Ware, Worthing, Barnard Castle (UK), Wavre, Rixensart (Belgium), St Amand (France), or Tres Cantos (Spain).
Travel: Please note that the successful applicant will need to travel to sites across the network as part of the role. We anticipate travel will be approximately up to 40% of your time.
CLOSING DATE for applications: Monday 24th of August 2026 (COB).
Basic Qualifications:
We are looking for professionals with the following required skills:
- Degree in a relevant Scientific, Technical or Engineering discipline.
- Relevant and specific experience obtained from working in Steriles, Biopharm &/or Vaccines.
- Subject matter expertise / knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for Steriles/ Biopharm / Vaccines / Pharmaceutical Manufacturing and Packing.
- Experience in identifying and/or managing complex Quality and Compliance risks and issues.
Preferred Qualifications:
If you have the following skills and characteristics, it would be a benefit:
- Previous auditing experience preferred (e.g. Proficiency and experience in planning, performing and reporting Quality and Regulatory Compliance audits).
- Working knowledge and ability in evaluation of Data Integrity and ALCOA+ principles within the Pharmaceutical industry.
- Increasing knowledge of AI tools, applications and ways of working in the Pharmaceutical industry
- Auditor formal accreditation/certification.
- Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, VPs and Heads of Support Functions).
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK .
Skills
Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Quality Auditing, Risk Awareness, Technical Writing
French Salary Range / Fourchette salariale – France EUR 78,750 to EUR 131,250Spanish Sa
Location and market context
This role is based in Stevenage on-site. Local candidates benefit from being close to GSK's teams and regional hiring market. Confirm the exact in-office expectation and any relocation support with the employer.
About internal audit roles
Internal audit gives independent assurance over controls and risk. Technology, data, and AI audit skills are in rising demand as programs modernize. Roles like this one are typically evaluated against frameworks such as IIA standards, COSO, NIST AI RMF, and IT and data audit practices.
How to position yourself for this internal audit role
Strong candidates emphasize risk-based audit planning, control testing and evidence, clear findings and remediation tracking, and technology, data, or AI audit depth. In your resume and outreach, tie your experience to how GSK would apply IIA standards, COSO, NIST AI RMF, and IT and data audit practices, and lead with concrete outcomes rather than duties.
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