Associate Director, QA Ops

Responsibilities

• 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

Requirements

• 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
• Ready to shape the future of life sciences? Apply now .

Benefits

Additional Information

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. What you will get: 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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Lonza? Share your experience