Manager, Quality Assurance Operations

Role: Manager of Quality Assurance Operations overseeing GMP-compliant contract manufacturing for cell/gene therapy biologics at Genetix Biotherapeutics. Objectives: ensure proactive quality oversight of CMOs, compliance with regulations, and continuous improvement of quality systems. Responsibilities: lead external quality governance, review deviations, Change Controls, and validation documents; serve as QA contact for product complaints; monitor quality metrics; manage Quality Agreements; and oversee quality reviews such as APQRs. Requirements: Bachelor’s in Life Sciences or related field; 7+ years in QA within GMP biopharma, with strong experience in CMO oversight, deviations, CAPAs, and validation lifecycle; deep knowledge of cGMP (FDA, EMA, ICH), and cell/gene therapy manufacturing. Preferred: experience with lentiviral vectors and process validation. Skills: leadership in cross-functional governance, risk-based decision-making, stakeholder management, and operating in fast-paced CMO environments. High-value specifics include expertise in cell/gene therapy, biologics, and GMP quality systems. Work setup: hybrid in Somerville, MA (3 days onsite). The role emphasizes proactive risk management, high-quality deviation handling, and cross-functional collaboration to support manufacturing excellence in gene therapy.