Director, Clinical Quality

About the role

TScan Therapeutics is a clinical-stage biotech focused on developing innovative cell therapy products. We are seeking a Director of Clinical Quality to lead and oversee all aspects of quality assurance for clinical development programs, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies.

Responsibilities

• Strategic Leadership
• Develop, implement, and oversee the Clinical Quality Management strategy at TScan to ensure alignment with GCP and regulatory requirements (e.g., FDA, EMA, ICH).
• Provide strategic direction for clinical quality initiatives, focusing on risk-based quality management approaches.
• Compliance and Oversight
• Monitor clinical trial activities to ensure adherence to regulatory guidelines, including patient safety, data integrity, and protocol compliance.
• Oversee vendor qualification, performance monitoring, and quality agreements with CROs and other clinical vendors.
• Oversee the clinical quality audit program to ensure compliance and identify improvement areas.
• Lead the preparation, coordination, and management of regulatory inspections.
• Quality Assurance Activities
• Conduct GCP audits, including investigator sites, clinical vendors, and clinical systems such as trial master files, clinical databases, pharmacovigilance, etc.
• Identify quality risks and lead cross-functional teams to implement corrective and preventive actions (CAPAs).
• Manage quality events related to clinical trials.
• Collaboration and Training
• Serve as a quality representative on clinical operations teams, ensuring quality considerations are integrated into all stages of clinical development and trial operations.
• Develop and deliver GCP training programs for internal staff.
• Work closely with the Clinical Operations, Pharmacovigilance, and Medical stakeholders to ensure phase-appropriate procedures and processes are implemented and quality events are resolved per internal SOPs.
• Continuous Improvement
• Drive continuous improvement initiatives to enhance clinical quality processes and systems.
• Stay current on evolving regulations, industry trends, and best practices in cell and gene therapy.

Requirements

• Education:
• Bachelor's degree in life sciences, biotechnology, or a related field (advanced degree preferred).
• Experience:
• 10+ years of experience in clinical quality assurance, with a strong background in GCP.
• Demonstrated experience in cell and gene therapy or advanced biologics is highly preferred.
• Proven track record in managing regulatory inspections a plus.
• Experience with electronic quality management systems (eQMS).
• Skills and Competencies:
• In-depth knowledge of GCP regulations and guidelines (FDA, EMA, ICH).
• Strong leadership skills, with the ability to work cross-functionally and manage external consulting resources.
• 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.

About TScan

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

Do YOU have the anatomy of a TScanner?

Join a team passionate, fun, flexible, and team-oriented. If you're ready to make a difference in the lives of patients, 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.

Pay Range

$217,500 - $230,000

Pay Transparency

TScan Therapeutics pay ranges are established based on external market data from third-party compensation surveys and our internal benchmarking. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Individual compensation within this range is commensurate with a candidates specific qualifications, including education, overall experience, relevant experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role.