Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
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
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.
Clear All
0 Quality Assurance Director jobs found in Somerville, MA area