Senior Director, GMP QA Operations - Greater Boston

Job summary

The Senior Director, GMP Operational Quality Assurance, will oversee Site Quality Operations for the manufacturing of Cell & Gene therapy products.

Responsibilities

• Oversee quality operations for clinical and commercial Cell & Gene product manufacturing, including batch record review, batch disposition, and end-to-end manufacturing processes.
• Lead multiple teams across shifts, ensuring timely completion of quality activities and compliance with GMP standards.
• Manage batch release for US, Canada, UK, EU, and other markets, including QP certification and importation requirements.
• Identify risks, implement mitigations, and drive continuous improvement in quality processes.
• Lead Material Review Board (MRB) discussions, change control approvals, and support for audits/inspections.
• Develop and implement quality strategies for product lifecycle management.
• Mentor and develop teams, fostering a culture of quality and excellence.

Qualifications

• Bachelor's degree in engineering or life sciences (Master's preferred).
• 15+ years of relevant quality assurance experience in the biopharma industry, with 10+ years in leadership roles (Site Leadership Team experience preferred).
• Expertise in clinical to commercial product lifecycle, regulatory interactions (e.g., BLA, MAA submissions), and operational excellence (LEAN, Six Sigma, etc.).
• Strong leadership, communication, and problem-solving skills, with experience in matrix organizations.

Job description