Associate Director, Clinical Quality (GCP)

Company: TCR - Therapeutics Inc.
Location: Cambridge
Posted on: August 6, 2022

Job Description:

At TCR - Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA.We are looking for an enthusiastic, motivated Associate Director, Clinical Quality to provide oversight to the GCP systems and compliance of our clinical studies. You will report to our Director, Quality Assurance, and work closely with groups throughout the organization to ensure compliance with regulatory requirements and to support clinical initiatives. The individual in this role will be responsible for providing Quality support to the external and internal functions to ensure robust processes and systems are implemented to support the clinical programs. If you thrive in a highly collaborative, fast-paced environment and are looking for a role where you're given ownership and accountability to get results and make an impact, come grow your career with us.Responsibilities:

• Lead the GCP quality program including implementation of the GCP Quality Management System. This will include ownership and/or oversight of procedures, records, and business processes
• Form and leverage collaborative partnerships with key cross-functional stakeholders such as Clinical Leads, Regulatory Affairs, Research and Development, Manufacturing, and other relevant stakeholders.
• Develop and own the Clinical Vendor Quality Management program. This is expected to include risk-based strategy planning, compliance monitoring, and leading and performing audits of clinical sites, vendor, internal systems as well as clinical, data collection and processing activities.
• Lead/support inspection readiness and inspection preparation activities, including post-inspection and response generation.
• Identify, Develop, and Report GCP metrics for Management Review and own continuous improvement actions.
• Drive continuous improvement and knowledge management by monitoring and mitigating risks
• Represent Quality in clinical study teams and external parties including CROs, vendors, and investigator sites and promote a high level of quality and consistency across and within programs
• Provide review, content editing, and/or approval of clinical and R&D documents including regulatory submissions, study reports, protocols, and SOPs.
• Be accountable for defining and driving systemic/programmatic clinical data integrity by working collaboratively with CRO, site, and internal functional teams in compliance with regulations and study protocol and procedures.
• Provide expertise and guidance on GCP and applicable regulations to clinical teams to proactively identify compliance issues/risks and recommend/implement mitigations.Requirements:
  • Bachelor's degree in the biological sciences or related field, Master's degree preferred.
  • 10+ years of experience combining clinical monitoring and GCP-based quality assurance experience in the pharmaceutical/biotechnology field.
  • Experience influencing decisions and actions at third party/remote sites in Sponsor role.
  • Track record of successful application of GCP regulations and guidelines published by and interaction (written and verbal) with FDA and other health authorities.
  • Process-oriented, with the ability to demonstrate good judgment and decision-making.
  • Exceptional organizational skills and ability to deal with competing priorities.
  • Budget and contract staff management experience.
  • Experience with Protocol, ICF, CRF, CSR development and review.
  • Strong technical writing skills, specifically with effective report, investigation documents experience.
  • Excellent communication, collaboration, partnering, and influencing skills required, specifically demonstrated in working with remote/off-site third-party partners.

Keywords: TCR - Therapeutics Inc., Cambridge , Associate Director, Clinical Quality (GCP), Executive , Cambridge, Massachusetts