Associate Director, Clinical Quality (GCP)
Company: TCR - Therapeutics Inc.
Posted on: August 6, 2022
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
- 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
- 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
- Exceptional organizational skills and ability to deal with
- Budget and contract staff management experience.
- Experience with Protocol, ICF, CRF, CSR development and
- 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
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