Associate Director, QA Ops

About the role

The position is located in Portsmouth, New Hampshire. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

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

Qualifications

Qualification details not specified.

Skills

• Strategic and experienced in quality assurance
• Leadership experience in a GMP environment
• Technical expertise in cGMP regulations, sterile manufacturing, and cell therapy or biologics operations
• Experience with deviations, CAPA, change control, and quality investigations
• Knowledge of enterprise quality systems
• Analytical and decision-making skills
• Effective communication and leadership abilities

Benefits

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).

Pay

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

Schedule

The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

About Lonza

About 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. Ready to shape the future of life sciences? Apply now. Reference: R76930 Apply