Our client is a cell and gene therapy biotech based in London. Their aim is to develop treatments for patients living with serious diseases.
The QA Director oversees the implementation and maintenance of the QMS for Clinical and Pre-Clinical operations, ensuring compliance with GLCP regulations. You would also Collaborate with stakeholders and contribute to the Quality Leadership Team.
Responsibilities:
- Manage QMS for Clinical and Pre-Clinical operations, ensuring compliance.
- Provide proactive guidance in GLCP regulations and QMS.
- Oversee 3rd party vendor and supplier performance.
- Act as QA representative in clinical project meetings, guiding compliance.
- Lead on clinical quality matters in regulatory submissions and trials.
- Contribute to supplier selection and auditing.
- Manage Clinical Review Board Escalation process.
Qualifications:
- Science-based degree (BSc or MSc).
- 10 years' senior management experience in pharmaceutical Quality Assurance.
- Extensive knowledge of GCP/GLP regulations and successful QMS implementation.
- Experience in hosting regulatory inspections.