Director, Quality Assurance Operations
Job Description
<div class="content-intro"><p><strong>JOIN US!</strong></p> <p>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 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.adicetbio.com&esheet=54175567&newsitemid=20250108585728&lan=en-US&anchor=https%3A%2F%2Fwww.adicetbio.com&index=1&md5=9d942dbcdb299f0c9fe719a48148cd0e">https://www.adicetbio.com</a>.</p></div><p>Director, Quality Assurance Operations</p> <p> </p> <p>Adicet Bio is seeking an experienced and motivated Director, Quality Assurance Operations. The Director<br>of QA Ops is responsible for building and leading the QA Operations team and establishing relationships<br>with internal personnel and external consultants/contractors, as necessary to support QA activities and<br>responsibilities. This position will work cross-functionally with other departments such as:<br>Manufacturing, Facilities, QC, Supply Chain, IT, MSAT, Process Development, Regulatory, Program<br>Management, etc.</p> <p>The successful candidate must thrive in a fast-paced team environment, have excellent communication,<br>planning and organizational skills, and be able to independently manage timelines to meet Adicet’s<br>priorities and communicated goals. The successful candidate will have working experience and<br>knowledge leading cGxP QA activities during clinical development and commercialization of drug<br>candidates. The ideal candidate must have experience in providing QA support for regulatory<br>submissions of quality-related sections.<br> This opportunity requires onsite presence 3 days a week at our corporate headquarters in Redwood City, California.</p> <p><strong>Key responsibilities:</strong><br>• Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of<br>phase I/II/III investigational product, and compliance to 21 CFR Parts 210, 211, ICH Guidelines<br>and EU GMPs as applicable.<br>• Accountable for lot disposition activities including batch record review, in-process/release and<br>stability testing review, oversight of quality events relating to GMP product, process, or facility,<br>etc. Will lead by example to partner with cross functional groups to meet company objectives in<br>compliance with applicable regulatory guidelines.<br>• Review approval of development activities in preparation for GMP such as development<br>studies/reports, engineering activities, etc.<br>• Collaborates with cross functional teams and champions the Quality Risk Management Program.<br>• Responsible for the phase appropriate validation program.<br>• Serves as team leader in quality related discussions, investigations, risk assessments, change<br>controls, etc. to resolve potential product quality issues and to ensure they are appropriately<br>addressed and justified.<br>• Partners with Facilities and functional SMEs to support equipment qualifications and lifecycle<br>management.<br>• Collaborates with Quality Systems to manage the cGxP training program for internal<br>manufacturing related functions.<br>• Represents the organization during third-party audits and inspections as required.<br>• Provides technical expertise and guidance in conducting investigations in regard to quality<br>deviations, laboratory investigations/change controls systems for tracking statuses, follow