Associate Director/Director, Quality Assurance

TCR² Therapeutics Inc. is an immuno-oncology company developing novel cancer therapies that unleash the full signaling power of complete T cell receptors (TCR). TCR² has developed a unique proprietary TRuC™ platform which can reprogram the natural TCR complex to recognize specific antigens found on tumors where they elicit rapid killing of cancer cells. The company has demonstrated activity against both hematological and solid tumor targets in preclinical models and believes its TRuC™-reprogrammed T cells will serve as the engine for important therapies.  TCR² was founded by MPM Capital and has scientific operations in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories around the world.

The Associate Director/Director, Quality Assurance, will establish and oversee TCR²’s Quality Management System for GxP activities. The candidate will have experience working in Quality to support the development and production of TRuC™-T cell products.

Responsibilities:

  • Establish Quality Systems and SOPs to ensure compliance of Preclinical, Clinical and Manufacturing processes with regulatory requirements

  • Maintain quality system and update procedures and forms as needed

  • Review preclinical, clinical and manufacturing-related documentation in support of IND submissions to ensure GxP compliance

  • Establish and provide QA oversight for deviation management, CAPA, and change control systems/processes

  • Manage and host regulatory and partner inspections and audits

  • Develop and deploy compliance training programs

  • Promote and cultivate a culture of quality/compliance and operational excellence

Qualifications:

  • Bachelor’s Degree in life science or a related scientific discipline

  • 7-10 years’ experience in Quality Assurance roles supporting cell/gene therapy products, biologics, vaccines

  • 2+ years’ experience in a leadership or management role

  • Working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements

  • Experience with quality oversight and auditing of external vendors in a GxP environment

  • Demonstrated ability to successfully interact with regulatory health authorities at inspections

  • Self-motivated and comfortable in a fast-paced biotechnology environment with minimal direction

Interested candidates should send their resume to careers@tcr2.com