Senior Director, Quality Control

Role: Senior Director of Quality Control overseeing laboratory operations and testing for Vericel's cell therapy products. Objectives include ensuring product safety, regulatory compliance, and timely release through strategic leadership of QC activities. Responsibilities encompass setting QC strategy, managing internal and external testing, maintaining inspection readiness, leading investigations, and developing staff. The role involves collaboration with manufacturing, quality assurance, regulatory, and supply chain teams to support process validation, product disposition, and regulatory submissions. The position requires representing QC during audits and inspections, ensuring data integrity, and improving laboratory systems and workflows. Leadership of QC personnel, budgeting, and performance metrics are integral. Qualifications: Bachelor's in life sciences or related field, with 12+ years in regulated pharma, biologics, or cell therapy industries, including 8+ years of leadership managing technical teams. Expertise in GMP, regulatory standards, laboratory investigations, and data integrity is essential. Preferred experience includes cellular therapies, regenerative medicine, microbiology, and laboratory information systems. Work setup is onsite in Burlington and Cambridge, MA, with a standard Monday-Friday schedule. The role emphasizes cross-functional collaboration, inspection readiness, and continuous process improvement in a high-stakes biologics manufacturing environment.