Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. 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 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.
Our Quality team ensures the utmost quality and compliance across Adaptimmune and fosters an environment of partnership and collaboration where everyone is responsible for quality. Ensuring everything is right the first time, every time is our mission. As a member of the Quality team, you become a part of a diverse and inclusive global organization which maintains quality oversight for every aspect of the manufacturing process from start to finish. This includes, but is not limited to, raw materials, vector, supplier quality, audits and inspections, training, quality systems, quality operations, quality control, contract testing labs, and contract manufacturing organizations. Come join a team where our patients are at the center of everything we do and where quality leads the way!
Quality Assurance and Quality Control are responsible for the timely testing, review, and release of life-saving medicine. The Quality team has a hand in all matters relating to manufacturing, routine batch testing, regulatory updates/requirements, process development, stability/raw material control, and much more. Being on the team at Adaptimmune allows an individual to fully immerse themselves into a clinical trial from the initiation via a new IND all the way through to a commercial manufacturing product.
Primary Responsibility
The Quality Assurance Manager is responsible for facilitating and ensuring the timely release of products through the management quality assurance functions. Those functions may include but is not limited to the oversight and approval of laboratory protocols and reports, data review, batch record review, deviations, product complaints, change controls, and CAPAs using the quality management system. The QA Manager may also support calibration and validation document reviews when necessary. The QA Manager role is a key leadership role responsible for leading a team of QA specialists to ensure products are delivered on time and to drive continuous improvement.
Key Responsibilities
Qualifications & Experience
Required
Desirable
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.