Quality Audit Manager
| Posting date: | 09 October 2025 |
|---|---|
| Salary: | £55,000.0 to £60,000.0 per year |
| Additional salary information: | £55,000 - £60,000 |
| Hours: | Full time |
| Closing date: | 08 November 2025 |
| Location: | London, London, EC4N 7BL |
| Remote working: | On-site only |
| Company: | Hays Specialist Recruitment |
| Job type: | Permanent |
| Job reference: | 4718737_1759998214 |
Summary
About the CompanyJoin 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 RoleWe 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 RequirementsEssential:
- 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.