Director of Quality Assurance
5 days ago
Adaptimmune is a leading cell therapy company with a strong commitment to quality and excellence. We are seeking a highly skilled and experienced Director, Quality Assurance to join our team.
Job Summary:
The Director, Quality Assurance will be responsible for leading our Quality Assurance department and ensuring that our clinical trials, external manufacturing, quality systems, research and development, and regulatory activities are conducted in accordance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations.
Key Responsibilities:
- Develop and implement quality processes and procedures to ensure compliance with GCP and GMP regulations.
- Lead a team of QA specialists to ensure patient therapies are delivered on time and drive continuous improvement.
- Collaborate with Clinical Operations, Contract Research Organizations, Contract Manufacturing Organizations, Medical Affairs, Regulatory, and Qualified Persons to ensure quality oversight.
- Develop and maintain Phase Appropriate Quality processes and procedures supporting GCP and GMP.
- Implement and oversee the global change management program.
- Serve as the main contact with CMOs and QPs to ensure timely closure of records for patient material release.
- Prepare for and guide pivotal trials and commercial operations.
Qualifications & Experience:
We are seeking a candidate with a strong background in pharmaceutical sciences, physical sciences, or related life sciences. The ideal candidate will have a minimum of years of experience in the pharmaceutical, biologics, biotech environment or health industry with demonstrated knowledge or experience in GCP Compliance.
The candidate should have a thorough understanding of clinical drug development, GMP, GCP, and familiarity with regulatory requirements for the conduct of clinical trials, including investigator-initiated studies.
The candidate should also have advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
We are an equal opportunities employer and welcome 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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