CK Group are recruiting for a GCP Quality Assurance Manager to join an innovative biotechnology company with a very promising lead candidate in a Phase II program and others in Phase I. This will be a partially office-based role near Oxford.
Up to £75,000 per annum.GCP QA Manager Role:
As GCP Quality Assurance Manager you will provide operational support across all GCP QA activities, including managing the QMS system and working closely with internal and external colleagues to develop GCP processes in line with regulatory and organizational requirements.
Key duties will include:
- Preparation and management of quality project plans.
- Collation of quality KPIs and management of any shortfalls.
- Leading continuous GCP process improvement activities.
- Delivery of company-wide GCP training.
- Management of the GCP audit program to include audits of investigator sites, vendors, processes, systems and study documents.
- Ensuring constant inspection readiness and supporting regulatory inspections.
As GCP QA Manager you will require:
- A relevant Life Science degree.
- Extensive GCP QA experience gained in an industrial setting.
- GCP auditing experience, including on-site auditing of vendors and clinical trial sites.
- Understanding and experience of International ICH-GCP and clinical quality laws, regulations and guidelines.
- Experience of regulatory inspections and interacting with regulatory authorities.
For more information or to apply for this GCP QA Manager position, please contact Jim Gleeson on 01438 842973 or email email@example.com, quoting job ref 50985.
It is essential that applicants hold entitlement to work in the UK.