Director, Quality Assurance Operations

JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com . Director, Quality Assurance Operations Adicet Bio is seeking an experienced and motivated Director, Quality Assurance Operations. The Director of QA Ops is responsible for building and leading the QA Operations team and establishing relationships with internal personnel and external consultants/contractors, as necessary to support QA activities and responsibilities. This position will work cross-functionally with other departments such as: Manufacturing, Facilities, QC, Supply Chain, IT, MSAT, Process Development, Regulatory, Program Management, etc. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and be able to independently manage timelines to meet Adicet’s priorities and communicated goals. The successful candidate will have working experience and knowledge leading cGxP QA activities during clinical development and commercialization of drug candidates. The ideal candidate must have experience in providing QA support for regulatory submissions of quality-related sections. This opportunity requires onsite presence 3 days a week at our corporate headquarters in Redwood City, California. Key responsibilities: • Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational product, and compliance to 21 CFR Parts 210, 211, ICH Guidelines and EU GMPs as applicable. • Accountable for lot disposition activities including batch record review, in-process/release and stability testing review, oversight of quality events relating to GMP product, process, or facility, etc. Will lead by example to partner with cross functional groups to meet company objectives in compliance with applicable regulatory guidelines. • Review approval of development activities in preparation for GMP such as development studies/reports, engineering activities, etc. • Collaborates with cross functional teams and champions the Quality Risk Management Program. • Responsible for the phase appropriate validation program. • Serves as team leader in quality related discussions, investigations, risk assessments, change controls, etc. to resolve potential product quality issues and to ensure they are appropriately addressed and justified. • Partners with Facilities and functional SMEs to support equipment qualifications and lifecycle management. • Collaborates with Quality Systems to manage the cGxP training program for internal manufacturing related functions. • Represents the organization during third-party audits and…