Director, External Quality

TScan Therapeutics•Waltham, MA

1d•Hybrid

About The Position

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 Clinical Quality professional to join our team as Director of Clinical Quality to lead and oversee all aspects of quality assurance for clinical development programs at TScan, ensuring compliance with Good Clinical Practice (GCP), 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 within clinical research, a strong understanding of the regulatory landscape for cell and gene therapy, and the ability to collaborate effectively across cross-functional teams. 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.

Requirements

Bachelor’s degree in life sciences, biotechnology, or a related field (advanced degree preferred).
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).
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.

Responsibilities

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.
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.
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.
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.
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.