We are looking for a Director, Quality Assurance, to join our growing Quality Assurance department to provide quality oversight for our clinical trials, external manufacturing, quality systems, research and development, and regulatory. You will report to the Senior Director, Site Head of Quality and work closely with Clinical Operations, our Contract Research Organizations, Contract Manufacturing Organizations, Medical Affairs, Regulatory, and Qualified Persons as needed. The Director role is a ... more details
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary Responsibility
We are looking for a Director, Quality Assurance, to join our growing Quality Assurance department to provide quality oversight for our clinical trials, external manufacturing, quality systems, research and development, and regulatory. You will report to the Senior Director, Site Head of Quality and work closely with Clinical Operations, our Contract Research Organizations, Contract Manufacturing Organizations, Medical Affairs, Regulatory, and Qualified Persons as needed.
The Director role is a key leadership role responsible for leading a group of QA specialists to ensure patient therapies are delivered on time and drive continuous improvement. As the Director, QA you will be primarily responsible for developing, improving and maintaining Phase Appropriate Quality processes and procedures supporting Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), including implementation and oversight of the global change management program. The Director role will also serve as the main contact with the CMOs and QPs in ensuring timely closure of records for patient material release to drive a successful patient experience. This role will be instrumental at preparing for and guiding us into pivotal trials and commercial operations.
Key Responsibilities
- 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.
- Manage partnership with drug product manufacturer to ensure the manufacturing and release of raw materials and drug substances.
- Implementation, oversight and administration of global change management program.
- 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.
- Build and lead quality teams of Managers and/or Specialists to execute and oversee day-to-day activities.
- Serve on the Quality Leadership Team and Extended Global Technical Operations Leadership Team to support cross-functional initiatives and collaboration.
- 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.
- 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.
- Implement GxP-compliant policies and procedures that are consistent, robust and integrated into the TCR2 Quality Management Systems.
- 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.
- Champion continuous improvement of Data Integrity Compliance
- Write and/or review applicable IND, BLA, or other regulatory submission sections.
- Drive continuous improvement by implementing tools, systems, and processes to identify pinch points and drive resolution.
Qualifications & Experience
Required
- BS or MS in Pharmaceutical Sciences, Physical Sciences, or related Life Sciences.
- Minimum of 10-12+ 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 (FDA, Health Canada, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies
- 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.
- 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
- Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
- Thorough understanding of drug development and commercialization process including strong knowledge of cGMP US and EU regulations/clean room experience.
- Experience bringing new products through development to commercialization.
- Proficient knowledge of root cause analysis tools and CAPA plans to address product impact.
- Ability to lead project teams and work collaboratively to drive right first time to patient initiatives.
- Ability to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management System.
Desirable
- Previous experience working in QA within cell and gene therapy.
- Experience working with human T-cells, primary human cells, or similar biological systems.
- Ability to lead a group of QA specialists
- Previous experience working collaboratively with a CMO and Qualified Person in EU
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team 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. It is our intent that all qualified applicants will receive equal consideration for employment.
