Audit Senior Lead (EMEA GMP Audit) in Ware

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.

The purpose of the Audit Senior Lead role is to perform and manage GMP (Good Manufacturing Practice) and Compliance audits of 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 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. Strong communication and influencing skills will be key to success.

Key Responsibilities include:

• 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).
• 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.
• Performing Unannounced audits.
• Performing for-cause audits based on regulatory actions or identified risk.
• Performing 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 objective 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), Siena, Parma (Italy), Wavre, Rixensart (Belgium) 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.

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 / Vaccines / Pharmaceutical industries.
• 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.

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.