Senior Manager, QA Operations

About the role

TScan is seeking an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager, supporting our internal GMP Cell Therapy manufacturing. This hands-on managerial role is based at our cGMP Manufacturing site in Waltham, MA and directly supports clinical cell therapy manufacturing and commercialization activities. The ideal candidate will have GMP manufacturing experience, preferably in cell and gene therapy, and thrive in a fast-paced, collaborative startup environment. This position may include 20-30% weekend work (either Saturday or Sunday) to support Clinical Manufacturing.

Responsibilities

• Manages, coaches, and develops the growing team of QA Specialists.
• Provides QA oversight of production, QC, and supply chain operations through review/approval of test records for batch release, SOPs, Certificates of Analysis (C of As), and on-the-floor oversight.
• Offers QA/Compliance guidance and decisions to production, QC, MSAT, and supply chain teams.
• Initiates and owns CAPAs, Deviations, change controls, and leads strategic discussions for investigations related to operations or batch release.
• Reviews and approves Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), and Quality Plans related to manufacturing operations.
• Contributes to Annual Product Reviews for production, QC, and supply chain.
• Supports the training program for QA operations specialists, including curricula for raw material dispositions, batch issuance, batch record review, and release training.
• Drives continuous quality improvement for manufacturing operations and partners with production, QC, and supply chain teams to optimize efficiency and monitor/escalate issues.
• Collaborates with the QA systems team and cross-functional teams to deliver results.
• Leads internal audits for the QA operations team and ensures inspection readiness.
• Acts as Deputy to the Quality Assurance Operations Head.
• Promotes a high standard of Quality Culture and drives compliance throughout the organization.

Requirements

• BS degree in a relevant scientific discipline (required).
• 10+ years of relevant biotech/pharma industry experience, with at least 3 years in Aseptic GMP manufacturing Operations and Quality Assurance covering GMP manufacturing operations.
• Experience supervising/managing direct reports.
• Experience working with Phase 1 through commercial products and building compliance.
• Proven track record in supporting GMP Manufacturing Operations and operating in full compliance with global cGMP requirements.
• Successfully managed inspections by major Health Authorities (e.g., US FDA).
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations.
• Proven ability to manage multiple projects with moderate resource requirements, risk, and/or complexity.
• Strong data tracking, trending, and analysis skills.
• Strong communication skills; a team player who can lead, mentor, and inspire others.
• Gene or cell therapy product experience (preferred).
• Demonstrated success in delivering key milestones against tight timelines.
• Ability to prioritize, manage time well, multitask, and troubleshoot.

Benefits

TScan offers a vibrant, innovative work environment with approximately 40,000 square feet of premium lab and office space. The company fosters a culture of camaraderie, professionalism, and flexibility, with a team-oriented, driven, and passionate workforce.

Pay

Pay range: $160,000–$180,000. This role is eligible for an annual bonus and annual equity awards. Individual compensation within this range is commensurate with a candidate’s specific qualifications, including education, overall experience, relevant experience, and specific skills.

Schedule

This position may include 20-30% weekend work (either Saturday or Sunday) to support Clinical Manufacturing.