Associate Director, QA Ops (Biotech)

TL;DR

Associate Director, QA Ops (Biotech): Providing quality oversight of cGMP manufacturing activities within cell therapy operations with an accent on sterile processing and regulatory compliance. Focus on managing QA staff, resolving complex quality issues such as deviations and CAPA, and ensuring audit readiness for regulatory inspections.

Location: Must be based in Portsmouth, NH

Company

A global leader in life sciences with 30+ sites across five continents, specializing in the manufacture of advanced medicines and therapies.

What you will do

• Provide end-to-end quality oversight of cGMP manufacturing operations, including sterile processing across Grades A/B/C/D environments.
• Ensure alignment with global quality standards, regulatory requirements, and customer Quality Agreements.
• Partner with cross-functional teams (Manufacturing, MSAT, Engineering, QC) to resolve complex quality issues, deviations, and change controls.
• Lead key quality governance forums, including the Change Control, Deviations Review Board, and Site Quality Council.
• Manage, develop, and mentor QA staff, including resource planning and performance management.
• Support regulatory inspections and customer audits to ensure audit readiness and effective response.

Requirements

• Bachelor’s degree in science, Engineering, or a related field (MS/PhD preferred).
• 8–12 years of QA experience within biotechnology, pharmaceutical, or regulated manufacturing environments.
• Demonstrated leadership experience managing and developing teams within a GMP environment.
• Deep knowledge of cGMP regulations, sterile manufacturing, and cell therapy or biologics operations.
• Experience with enterprise quality systems such as TrackWise, LIMS, ELN, or SAP.
• Must be based in Portsmouth, NH.

Culture & Benefits

• Comprehensive health package including medical, dental, and vision insurance.
• Financial security with a 401(k) matching plan and performance-related bonuses.
• Insurance coverage for life, short-term, and long-term disability.
• Generous paid time off (PTO) and employee assistance programs.
• A global, inclusive culture rooted in Collaboration, Accountability, Excellence, Passion, and Integrity.