Quality Manager - GCP (with GMP awareness)
Hybrid · London, England, United Kingdom
Job Summary
Quality Manager – GCP with GMP awareness responsible for planning, coordinating, and executing QA activities across global clinical programs. Key duties include QA support across functions, QA review of quality matters to ensure regulatory compliance, management of the Quality Management System (QMS) via Veeva, development and maintenance of audit programmes, creation of QA reports (including CAPAs, deviations, and investigations), ensuring patient safety and data integrity throughout the clinical trial lifecycle, staying updated on regulatory changes (US CFR, EU CTD, ICH, and local requirements), and liaising with regulatory inspections. Requires a life sciences degree and at least five years in pharma, with three years in GCP QA and GMP exposure; willingness to travel; strong communication and collaboration skills; and experience with eQMS like Veeva. The role supports a hybrid work model with occasional remote work and face-to-face collaboration on site.
Required Qualifications
- Degree in life sciences (pharmacy, chemistry or equivalent)
- Minimum five years of pharmaceutical industry experience including early phase clinical trials
- Three years minimum in GCP QA with some GMP exposure
- Strong understanding of global regulatory requirements for clinical research (UK Statutory instruments, US CFR, EU-CTD) and GXPs
- Experience implementing or working with eQMS (e.g., Veeva Quality Docs, Vault Training, QMS)
- Ability to travel within the UK and abroad if required
- Excellent communication and cross-functional collaboration skills
- Proactive, independent, and able to manage multiple projects
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