A hands-on quality lead to run GCP and GMP oversight for Fenmoor's clinical supply chain and prepare the company for its first regulatory inspection.
What you will do
- Run the quality management system and document control
- Plan and lead vendor and site audits
- Prepare the company for inspection readiness
- Train teams on deviations, CAPA and change control
What you will bring
- Six or more years in GxP quality assurance
- Audit experience with CROs or manufacturing partners
- Clear writer of procedures and audit reports
- Able to work on site in Cambridge four days a week
What is offered
- Bonus up to 10%
- Private medical cover
- Relocation support
How you will be assessed
Every candidate for this role is assessed on the same four criteria, by the consultant and by the hiring team:
- Audit practice
- Leads audits and writes clear reports
- Quality systems
- Has run a QMS in a regulated company
- Inspection readiness
- Has prepared a team for an inspection
- Training
- Coaches teams on CAPA and change control