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Director, Quality Assurance and Compliance
2 months ago
We are seeking a highly experienced and skilled Director, Quality Assurance and Compliance to join our Quality Assurance department at Adaptimmune. As a key member of our team, you will be responsible for providing quality oversight for our clinical trials, external manufacturing, quality systems, research and development, and regulatory activities.
Key Responsibilities- Quality Oversight: Serve as the primary QA contact for the oversight of all External Manufacturing and Testing for designated programs to ensure compliance with all GxP's from site qualification, collection, labeling, through product manufacturing and batch release to ensure compliance with all Regulatory requirements in the country the study is conducted.
- Partnership Management: Manage partnership with drug product manufacturer to ensure the manufacturing and release of raw materials and drug substances.
- Change Management: Implementation, oversight and administration of global change management program.
- Quality System Leadership: Serve as QA lead for quality system elements including Document Control, Training, Deviation Management, Internal and External Inspection, Supplier Management, Risk Management, Complaints, Recalls, etc.
- Team Leadership: Build and lead quality teams of Managers and/or Specialists to execute and oversee day-to-day activities.
- Cross-Functional Collaboration: Serve on the Quality Leadership Team and Extended Global Technical Operations Leadership Team to support cross-functional initiatives and collaboration.
- Audit and Compliance: Plan, oversee/perform and follow-up audits of CMOs, external laboratories, external suppliers and service providers. Support CRO and clinical trial site auditing as required.
- Metrics and Performance: Oversee and Manage QA metrics to ensure adherence to right first-time delivery of patient material.
- Quality Systems Development: Establish and maintain phase appropriate Quality Systems to support manufacturing, clinical studies, and research activities.
- Regulatory Compliance: Implement GxP-compliant policies and procedures that are consistent, robust and integrated into the TCR2 Quality Management Systems.
- Professional Expertise: Provide professional expertise and guidance on Good Clinical, Manufacturing, Laboratory, and Research Practices and applicable regulations to manufacturing, clinical development teams to proactively identify compliance issues/risks and recommend mitigation.
- Continuous Improvement: Champion continuous improvement of Data Integrity Compliance.
- Regulatory Submissions: Write and/or review applicable IND, BLA, or other regulatory submission sections.
- Process Improvement: Drive continuous improvement by implementing tools, systems, and processes to identify pinch points and drive resolution.
We are looking for a highly experienced and skilled professional with a strong background in Quality Assurance and Compliance. The ideal candidate will have:
- Education: BS or MS in Pharmaceutical Sciences, Physical Sciences, or related Life Sciences.
- Experience: Minimum of years of experience in the pharmaceutical, Biologics, biotech environment or health industry with demonstrated knowledge or experience in GCP Compliance.
- Regulatory Knowledge: Thorough understanding of clinical drug development, GMP, GCP, and familiarity with regulatory (FDA, Health Canada, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies.
- Audit and Compliance: 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.
- Leadership and Collaboration: Ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas.
- Team Player: Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
- Regulatory Expertise: Thorough understanding of drug development and commercialization process including strong knowledge of cGMP US and EU regulations/clean room experience.
- Product Development: Experience bringing new products through development to commercialization.
- Root Cause Analysis: Proficient knowledge of root cause analysis tools and CAPA plans to address product impact.
- Project Leadership: Ability to lead project teams and work collaboratively to drive right first time to patient initiatives.
- Continuous Improvement: Ability to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management System.
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. We are committed to transforming the lives of people with cancer through our innovative approach to immunotherapy.
