Director, Quality Operations

Director, Quality Operations

Location: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.

The Director of Quality Operations provides strategic leadership for GMP compliance within customer-dedicated manufacturing areas, ensuring adherence to global quality standards and regulatory requirements. As a senior leader, they drive continuous improvement initiatives, foster a strong culture of quality awareness, and collaborate across departments to align on quality performance. This role directly manages quality staff, overseeing operational support, batch records, and lot release activities. They serve as the primary customer liaison, participating in Joint Quality Steering Committees to ensure expectations are met. Additionally, the incumbent manages resource allocation, staff development, and high-level decision-making for site escalations.

What you will get:

• Competitive salary and comprehensive benefits package

• Opportunities for career development and internal mobility

• Supportive and inclusive work environment

• Access to cutting-edge technologies and resources

• Flexible working arrangements where applicable

• Commitment to employee well-being and safety

• Collaborative culture that values innovation and excellence

Access to our full list of global benefits: https://www.lonza.com/careers/benefits

What you will do:

• Strategic Leadership: Develop and implements the overall quality strategy across manufacturing operations.

• Compliance Assurance: Ensure operational compliance with Customer Quality Agreements, SOPs, and regulatory requirements.

• Quality Management & Risk Resolution: Lead investigation of high-risk deviations, CAPA, and change controls in partnership with cross-functional teams.

• Audit & Inspection Support: Support customer audits and regulatory inspections.

• Metrics & Reporting: Track Key Performance Indicators (KPIs) and presents deviation trends to senior management.

• Lot Disposition: Execute final lot release and quality approval processes.

• Team Leadership & Mentoring: Manage staff, conducts 1-on-1s, and mentors staff to drive continuous improvement and career development

What we are looking for:

• Bachelor's degree in Life Sciences or equivalent experience

• 5-10 of QA experience with proven leadership skills

• Experience leading and managing direct reports with demonstrated coaching and mentoring capabilities

• Advanced knowledge of GMPs and regulations

• Demonstrated quality and strategic decision making skills

• Experience participating in, or leading, Domestic and International Regulatory Inspections preferred

• Experience in Corporate Quality System initiatives (Six Sigma, Lean, etc.) a plus.

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.

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