DIRECTOR, CLINICAL QUALITY ASSURANCE

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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, CLINICAL QUALITY ASSURANCE

Adicet Bio is seeking an experienced and motivated Director, Clinical Quality Assurance. The Director, Clinical Quality Assurance will play an essential role in developing, managing, and leading the GCP QA program to ensure that clinical trials are conducted in accordance with cGCP regulations, ICH guidelines, and any country specific regulations that might impact the clinical trial. This position will be responsible for ensuring that all clinical studies are performed in compliance with Adicet procedures and protocols and global regulatory requirements (FDA, EMA, ICH, etc.). The position is also responsible for execution of internal and external audit plans and activities, and the development and maintenance of GCP-related quality systems across the company.

The ideal candidate is a strategic leader with deep expertise in GCP, clinical quality systems, and risk-based quality oversight. This is a full-time position reporting to the Head of Quality Assurance and is located at our corporate headquarters in Redwood City, California.

Key Responsibilities:

• Provide leadership, strategy, and compliance oversight in accordance with Good Clinical Practices (GCPs) and Good Clinical Laboratory Practices (GCLPs) for internal processes and Clinical Service Providers, including but not limited to CROs, Investigator Sites, Bioanalytical Laboratories, Data Management Vendors, etc.
• Develop and manage a risk-based clinical Quality Management System for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies. Author/review/approve clinical related SOPs/policies/forms as needed.
• Actively partner with appropriate cross functional teams to manage and oversee clinical deviations, CAPA plans, product complaints, etc.
• Participate in Adicet Clinical Operations teams study meetings and provide guidance on any site and vendor-related quality issues identified.
• Collaborate with clinical operations study leads to ensure Sponsor Oversight is maintained, documented, and improved in ongoing clinical programs.
• Provide quality oversight of the CRO-maintained and/or internal Trial Master File (TMF) to ensure the TMF is inspection-ready. Conduct TMF audits and periodicnquality reviews to assess for completeness, accuracy, and timeliness of documentation.
• Support inspection readiness efforts and the coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections. Manages inspection commitments, post-inspection activities, and corrective/preventative actions in a timely manner.
• Ensure clinical trials are performed in accordance with applicable study protocols and in compliance with cGCP and ICH guidelines through active monitoring of clinical sites.
• Manage the clinical supplier qualification program to ensure Sponsor Oversight of vendors.
• Reviews and provides oversight of clinical study documents, including but not limited to Investigator Brochures, Clinical Protocols, Clinical Study Reports, Case Report Forms, Informed Consent Forms.
• Work with CROs to create, and keep current, Quality Agreements, Monitoring Plans, etc., to ensure quality standards are met, and resolve issues promptly and effectively.
• Ensure timely execution of the cGCP Audit Plan. Support/Lead GCP Compliance audits of Investigator Sites, Clinical Research Organizations (CROs), and vendors in accordance with the Audit Plan.
• Support the administration of the company’s training program as it applies to Clinical. Conduct/supervise and document cGCP training for clinical team members, investigators, clinical site staff, and company employees as required.
• Provide oversight of contractors and consultants to ensure timely and quality deliverables.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends.
• Assist in the design, implementation and maintenance of the Adicet Quality System, including document drafting, review, finalization and training.