Director, Quality Control

We are seeking an experienced professional to serve as Director of QC, supporting release, characterization, and environmental monitoring (EM) testing for cellular drug products manufactured internally. Reporting to the Associate Vice President of QC and AD, the role requires expertise in compendial, cellular, molecular, and environmental monitoring within a cGMP facility, in a fast‑paced, collaborative environment. Responsibilities Maintain a culture of constant improvement and compliance with cGMP. Manage QC team execution of internal STAT and release testing for disposition of Phase 1/2 clinical trial drug products per target release timing. Ensure GMP lab is maintained in a constant state of compliance and inspection readiness. Support QMS compliance through timely review of documents and ensuring QC support of Quality/CMC documentation. Drive sense of urgency through effective meeting cadence and scope as well as appropriate delegation of tasks and duties. Support personnel development including efficient cross training and organizational design of QC release team. Manage QC QMR metrics reporting to Senior Leadership Team. Requirements Education: Masters and 12+ years of direct cGMP experience or BS and 15+ years or PhD and 10+ years. Experience in cell therapy manufacturing for clinical‑stage products strongly preferred. Deep knowledge of USP, EP, ICH, and Cell Therapy regulatory guidance. Management of cross‑trained multi‑disciplinary teams in an active cGMP release testing environment, including responsibility for COA generation and approval. Experience developing and managing stability programs in the clinical environment. Able to execute responsibilities at the Director level. Experience managing multi‑shift operations preferred. 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. Compensation Pay Range: $210,000 - $220,000 Annual bonus and equity awards are also included. Some roles may be eligible for overtime pay in accordance with federal and state requirements. Compensation within this range is commensurate with a candidate’s specific qualifications, including education, overall experience, relevant experience, and specific skills. #J-18808-Ljbffr