Associate Director, QA Ops

Associate Director, QA Ops

Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

Below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

We are seeking a strategic and experienced Associate Director, QA Operations, to provide quality oversight of cGMP manufacturing activities within our cell therapy operations. This role is a key member of the site Quality Leadership Team, responsible for ensuring compliance across sterile manufacturing environments while driving continuous improvement and fostering a strong culture of quality. The ideal candidate brings deep technical expertise, leadership experience, and the ability to partner cross-functionally to support operational excellence and regulatory compliance.

• 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 across all QA activities
• Partner with cross-functional teams (Manufacturing, MSAT, Engineering, QC, Validation, and Supply Chain) to resolve complex quality issues, including deviations, CAPA, and change controls
• Lead and participate in key quality governance forums, including Change Control, Deviations Review Board, CAPA Board, and Site Quality Council
• Manage, develop, and mentor QA staff, including resource planning, performance management, and talent development
• Drive continuous improvement initiatives to enhance quality systems, operational efficiency, and overall GMP compliance
• Support regulatory inspections and customer audits, ensuring audit readiness and effective response to findings

What we are looking for:

• Bachelor's degree in science, Engineering, or a related field; advanced degree (MS/PhD) preferred
• 8–12 years of experience in quality assurance within a biotechnology, pharmaceutical, or regulated manufacturing environment
• Demonstrated leadership experience managing and developing teams within a GMP environment
• Strong knowledge of cGMP regulations, sterile manufacturing, and cell therapy or biologics operations
• Proven experience leading or supporting deviations, CAPA, change control, and quality investigations
• Experience with enterprise quality systems (e.g., TrackWise, LIMS, ELN, SAP or similar platforms)
• Strong analytical and decision-making skills, with the ability to interpret data and drive risk-based quality decisions
• Excellent communication and leadership skills, with the ability to influence stakeholders and operate effectively in a cross-functional, matrixed environment

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.