Associate Director/Director, External Quality

Position Summary:

TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality professional to join our team as Associate Director/Director of External Quality to lead and oversee all aspects of external GMP quality assurance activities supporting clinical development programs at TScan, ensuring compliance with Good Manufacturing Practice (GMP), regulatory requirements, and company policies. This role is instrumental in supporting clinical trials, advancing the development of innovative cell therapy products, and maintaining a culture of quality across the organization.

The ideal candidate will possess deep expertise in quality assurance in a GMP manufacturing environment, a strong understanding of the regulatory landscape for manufacturing cell and gene therapy products, and the ability to collaborate effectively across cross-functional teams including external partners. Someone who enjoys a fast-paced, collaborative, and vibrant culture and excels as a team player with a sense of urgency will thrive in this role.

This role will be based out of Waltham, MA and will require up to 25% travel to support CMO activities.

Responsibilities:

• Strategic Leadership:
  • Develop, implement, and oversee the procedures and policies to support and govern the external Quality Management strategy at TScan to ensure alignment with GMP and regulatory requirements (e.g., FDA, EMA, ICH).
  • Provide strategic direction for quality initiatives, focusing on risk-based, phase appropriate, quality management approaches.
  • Serve as a quality thought leader supporting TScan’s cell therapy programs from post-IND through late-stage clinical development and into commercialization.

• Compliance and Oversight:
  • Monitor CMO manufacturing activities to ensure adherence to TScan approved documents such as specifications, batch records and shipping documents.
  • Assist with vendor qualification and performance monitoring, and directly manage quality agreements with CMOs and other GMP vendors.
  • Act as the primary TScan point person in support of the preparation, coordination, and management of regulatory inspections at CMO’s.
  • Ensure GMP compliance is maintained across all stages of outsourced manufacturing and quality oversight.
• Quality Assurance Activities:
  • Act as the primary liaison with CMO’s to approve master documents and executed records in support of GMP manufacturing for critical starting materials and final drug product
  • Coordinate cell therapy drug product release activities at CMO’s including acting at TScan approver for COA’s and COC’s as necessary.
  • Liaise with Qualified Person responsible for EU and UK release to ensure on time release of product
  • Review and approve quality system records such as deviations, CAPA’s and change controls
  • Assist with CMO related regulatory submissions as required
• Collaboration and Training:
  • Serve as external quality representative on program and CMC teams , ensuring TScan quality considerations are communicated and maintained at CMO’s
  • Work closely with the internal stakeholders (CMC, Clinical Operations, Program/Project management) to ensure CMO manufacturing quality status is regularly communicated including participation on relevant program teams and scheduling forums.
  • Create and foster a highly collaborative working relationship with CMO quality and CMC representatives ensuring TScan’s business needs and sense of urgency are reflected in CMO deliverables.
  • Promote a culture of transparency and continuous improvement within both internal and external quality environments.
• Continuous Improvement:
  • Identify quality risks and continuous improvements and collaborate with CMO partners to implement corrective and preventive actions (CAPAs).
  • Stay current on evolving regulations, industry trends, and best practices in cell and gene therapy GMP manufacturing.

Requirements:

• Education:
  • Bachelor’s degree in life sciences, biotechnology, or a related field (advanced degree preferred).
• Experience:
  • 10 years of experience in quality assurance, with a strong background in GMP manufacturing and product release.
  • Demonstrated experience in cell and gene therapy or advanced biologics is preferred.
  • Proven track record in managing CMO’s is highly preferred.
  • Experience with electronic quality management systems (eQMS).
• Skills and Competencies:
  • In-depth knowledge of GMP regulations and guidelines (FDA, EMA, ICH).
  • Strong leadership skills, with the ability to work cross functionally and manage external contractual relationships.
  • Excellent problem-solving, analytical, and decision-making abilities.
  • Exceptional communication and collaboration skills, with experience working in cross-functional teams.
  • Ability to manage multiple priorities in a fast-paced, dynamic environment.
  • Must be able to travel up to 25% of time to support CMO activities.

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

Recruitment & Staffing Agencies

TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.