DIRECTOR, CLINICAL QUALITY ASSURANCE

Company: Adicet Bio, Inc
Location: Redwood City
Posted on: March 31, 2025

Job Description:

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 .DIRECTOR, CLINICAL QUALITY ASSURANCEAdicet 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 periodic quality 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. Manage 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.
• Review and provide 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.
• Other duties as assigned.Qualifications:
  • B.S. degree or an equivalent amount of relevant experience.
  • 7-10+ years of experience working within the Clinical Operations, Regulatory, or Quality environment in the pharmaceutical or biotechnology industry.
  • Working knowledge of Local, State, Federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements across the world.
  • Thorough understanding of Regulatory compliance requirements for the US FDA, and the European Union.
  • Auditor training/experience or certification.
  • Proven track record with FDA, EMEA and other Health Authorities.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Team and consensus builder, with definitive and authoritative decision-making ability.Pay Range:$186,000 - $257,000 USDAdicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.Apply for this job* indicates a required field
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Keywords: Adicet Bio, Inc, Redwood City , DIRECTOR, CLINICAL QUALITY ASSURANCE, Executive , Redwood City, California