Associate Director, Quality Assurance Operations - LSA

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza AG offers the opportunity to be the Associate Director, Quality Assurance Operations - LSA in New Hampshire, USA! You will lead central initiatives to boost quality standards and ensure cGMP compliance!

• Own the overall quality strategy across Manufacturing Operations.
• Provide general direction and support, acting as a point of escalation for Quality Assurance staff and customers.
• Ensure objectives are met and align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Partner with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to resolve high-risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Attend and/or co-chair Change Control Committee, Deviations Review Board, and CAPA Board meetings.
• Support customer audits and regulatory inspections.
• Manage and supervise Key Performance Indicating Quality Metrics, including monthly/quarterly deviation trending reports for senior site management.
• Ensure site Lot Release/Disposition goals are met and system health is maintained.
• Sponsor and develop our lean culture, driving continuous improvement of our quality processes.
• Provide general direction for the department, developing team goals and ensuring continuous improvement.
• Conduct regularly scheduled meetings with staff to review objectives, provide support, feedback, and resolve issues.
• Participate in the hiring process, provide performance feedback, and support career development.
• Perform other duties as assigned, including reviewing and approving various documents (e.g., Product Quality Reports, Quality Agreements, Deviation Reports, filing reviews) and lot disposition.

• Bachelor’s Degree or equivalent experience.
• 5-10 years of related experience in Quality Assurance Operations.
• Proven track record to lead and manage a team optimally.
• Strong understanding of cGMP regulations and compliance requirements.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Strong problem-solving skills and attention to detail.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.