Director of Quality Assurance
4 days ago
Adaptimmune is a leading cell therapy company with a strong presence in the UK and US biotechnology hubs. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is built on trust, inclusion, collaboration, and a commitment to honesty and bravery in transforming the lives of people with cancer.
Key Responsibilities- Provide quality oversight for clinical trials, external manufacturing, quality systems, research and development, and regulatory.
- Develop, improve, and maintain Phase Appropriate Quality processes and procedures supporting Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
- Implement and oversee the global change management program.
- Serve as the primary QA contact for External Manufacturing and Testing, ensuring compliance with all GxP's.
- Manage partnerships with drug product manufacturers to ensure manufacturing and release of raw materials and drug substances.
- Lead quality teams of Managers and/or Specialists to execute and oversee day-to-day activities.
- Plan, oversee/perform, and follow-up audits of CMOs, external laboratories, external suppliers, and service providers.
- Oversee and manage QA metrics to ensure adherence to right first-time delivery of patient material.
- Establish and maintain phase-appropriate Quality Systems to support manufacturing, clinical studies, and research activities.
- BS or MS in Pharmaceutical Sciences, Physical Sciences, or related Life Sciences.
- Minimum of years of experience in the pharmaceutical, Biologics, biotech environment or health industry with demonstrated knowledge or experience in GCP Compliance.
- Thorough understanding of clinical drug development, GMP, GCP, and familiarity with regulatory requirements for the conduct of clinical trials.
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans.
- Ability to represent QA cross-functionally and globally, and to apply understanding of the team's place in the larger organization.
Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status, or other legally protected category.
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