Quality Audit Manager
JOB_53390534718737Job type
PermanentLocation
LondonWorking Pattern
Full-timeSpecialism
Quality Assurance And ValidationIndustry
PharmaceuticalsPay
£55,000 - £60,000
Quality Audits Manager | GMP/GDP | Lead Auditor | Global Pharma | London Hybrid | £55–60k
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.
Quality Audit ManagerJOB_533905347187372025-10-092026-01-06
Talk to Aleksandra Topalovic, the specialist consultant managing this position
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JOB_53390534718737