Lead Specialist, QA Validation

Role: Lead QAV Specialist overseeing commissioning, qualification, and validation activities at ElevateBio's Waltham facility, ensuring cGMP compliance in validation master plans, equipment, utilities, and lab systems. Responsibilities: manage QA oversight of validation processes, evaluate change controls and quality events, support risk assessments and technical reports, lead periodic reviews, and supervise a team of QA personnel. Collaborate with engineering and lab teams to track project milestones and ensure adherence to timelines, with potential support for electronic validation systems. Qualifications: Bachelor's degree with 5+ years (or advanced degree with fewer years) in QA, validation, or related fields; strong knowledge of 21 CFR, ICH, EU regulations; experience with facility commissioning/qualification, validation systems, and QMS tools like Blue Mountain CMMS; prior management experience is a plus. High-Value: focus on cell and gene therapy manufacturing, validation, and process equipment; experience with GMP manufacturing facilities, validation, and compliance in biopharma; familiarity with regulated environments and technical writing skills. Work Setup: onsite in Waltham with physical activity requirements; no travel specified.