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Quality audit manager

London
Hays Construction And Property
Audit manager
Posted: 27 October
Offer description

About the Company Join a leading global pharmaceutical organisation with operations across Europe, North America, and Asia-Pacific. This innovative company specialises in complex medicines, including specialty generics, biosimilars, and originator brands. With a strong focus on quality, speed to market, and patient-centric innovation, they support a wide range of therapeutic areas such as gastroenterology, endocrinology, and rare diseases. You'll be part of a collaborative, fast-paced environment that values entrepreneurial thinking and continuous improvement. About the Role We are seeking a Quality Audits Manager to lead and manage external GMP/GDP audits across a diverse global supplier network. This UK-based role is ideal for an experienced pharmaceutical quality professional with a strong background in regulatory compliance and vendor auditing. Key Responsibilities: Lead and conduct risk-based external audits in line with EU GMP, GDP, and global regulatory standards Manage the audit lifecycle, including planning, execution, reporting, and CAPA follow-up Oversee vendor qualification and lifecycle management of approved suppliers Collaborate cross-functionally with regulatory affairs, supply chain, and quality operations Support inspection readiness and contribute to SOP/documentation updates Travel nationally and internationally for audits Attend the London office twice per week (Tuesdays mandatory) Candidate Requirements Essential: Lead Auditor certification (external audits) Minimum 5 years' experience in pharmaceutical quality auditing In-depth knowledge of EU GMP/GDP and international regulatory frameworks Experience auditing sterile manufacturing, biosimilars, and medical devices Degree in Pharmacy, Chemistry, Microbiology, or related field Key Skills: Strong organisational and time management skills Excellent communication and stakeholder engagement Ability to manage multiple priorities and make risk-based decisions Calm under pressure with leadership potential Desirable: Experience with SAP ERP systems Familiarity with health authority inspections (e.g. MHRA, EMA, FDA) What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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