GSK
Biopharm
AuditSeniorLead(EMEAGMPAudit)
“Audit Senior Lead (EMEA GMP Audit) at GSK. Skills: GMP Auditing, Quality Assurance, Regulatory Compliance, Pharmaceutical Industry Expertise. Perform and manage GMP and Compliance audits of Biopharm, Vaccines, and Pharmaceutical facilities. Evaluate compliance of GSK Global Supply Chain facilities with GMP, applicable policies and procedures, and regulatory and contractual commitments”
What You'll Achieve.
identification, prioritisation, and monitoring of quality, compliance, and technical risks; ensure senior management is appraised of identified risks; ensure appropriate corrective action plans are implemented
Industry & Context.
identification, prioritisation, and monitoring of quality, compliance, and technical risks
Travel approximately up to 40% of your time
What They're Looking For.
Must Have
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
Nice to Have
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)
What You'll Do.
Perform and manage GMP and Compliance audits of Biopharm
and Pharmaceutical facilities
Evaluate compliance of GSK Global Supply Chain facilities with GMP
applicable policies and procedures
and regulatory and contractual commitments
Audit Global Supply chain (internal and external) manufacturing facilities and operations
Local Operating Companies (LOCs)
R&D and Logistics Service Providers (LSPs)
Provide sterile manufacturing subject matter expertise
Manage complex stakeholder engagement for audits
Perform unannounced audits
Perform for-cause audits based on regulatory actions or identified risk
quality system-specific
Perform audits against risk mitigation plans or regulatory citation commitments
and objective audit reports
Ensure senior management is appraised of identified risks
Ensure appropriate corrective action plans are implemented
How You'll Work.
Team & Collaboration
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)
Communication Scope
communication and influencing skills
Process & Methodology
Manage complex stakeholder engagement for audits
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