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Associate Director Clinical Quality Assurance

Adicet Bio, Menlo Park, California

Position Description:

JOIN US!
Adicet Bio, Inc is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CAR) and T cell receptor-like antibodies (TCRL), to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. For more information, please visit our website at http://www.adicetbio.com.
 
ASSOCIATE DIRECTOR CLINICAL QUALITY ASSURANCE
Overview:
Adicet Bio is seeking an experienced and motivated Associate Director Clinical Quality Assurance. The Associate Director, Clinical Quality Assurance will play an essential role in developing and managing 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, FDA guidelines and regulations, and ICH guidance and regulations. 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 candidate will be responsible for managing clinical quality aspects. This is a full-time position reporting to the Head of Quality Assurance and is located at our corporate headquarters in Menlo Park, California.
 
Key Responsibilities:
  • Support Clinical Quality Management System (CQMS), for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies. Authorship/review of additional SOPs/policies where there may be gaps identified.
  • 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.
  • Support inspection readiness efforts which may include mock internal site and vendor audits.
  • Support the coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections.
  • 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.
  • Participate in the clinical supplier qualification program to ensure Sponsor Oversight of vendors.
  • Participate/Lead audits and reviews 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 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.
  • Personal Development:
  • 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.

Qualifications:

  • B.S. degree or an equivalent amount of relevant experience.
  • 7+ 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.

Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.

Benefits:
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
 

To Apply:

Please visit this webpage and search for "Associate Director Clinical Quality Assurance" to apply for the position: https://www.adicetbio.com/careers/openings/
 
Adicet Bio 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.