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.

Are you ready to join a world-class team at Lonza AG? Our daring growth continues, and we're seeking a QA Specialist V-QMS to help us maintain outstanding standards in our quality management systems (QMS)! This role is pivotal to ensuring compliance with cGMP regulations and driving continuous improvement in our quality processes. Located in beautiful New Hampshire, USA, this opportunity offers you the chance to work in a collaborative environment where your ideas can make a genuine impact!

Key responsibilities:

• Serve as the Quality Subject Matter Expert on Deviation, CAPA, and Change Management programs; mentor and train site personnel on these processes.
• Lead and co-chair daily deviation review board and biweekly CAPA and change control board meetings, including agenda setting, facilitation, and minute-taking.
• Collaborate routinely with internal personnel to address blocking issues, critical issues, and closure of QMS records.
• Prepare and supervise key performance indicator quality metrics for the department, Quality Council, and the business.
• Support internal/customer audits and regulatory inspections.
• Perform monthly and quarterly deviation trending analyses.
• Mentor QA Compliance Specialists and provide direct support to management.
• Lead quality requests for reopening quality records in the TrackWise system.
• Find opportunities to improve QMS processes and lead continuous improvement projects from planning to execution.
• Attend team meetings and provide input related to activities performed, challenges, and blocking issues to management.
• Apply Data Integrity principles in compliance with Lonza DI policies, guidelines, and procedures.
• Perform other duties as assigned.

Key requirements:

• Proven expertise in Quality Management Systems and cGMP regulations.
• Outstanding communication and collaboration skills.
• Ability to lead and facilitate meetings effectively.
• Strong analytical skills for tracking and trending quality metrics.
• Experience with internal and customer audits as well as regulatory inspections.
• Proficiency in the TrackWise system or similar QMS software.
• Demonstrated ability to mentor and support less experienced staff.
• Strong project management skills, including defining project plans and completing deliverables.
• Adherence to Data Integrity principles and Lonza's DI policies.
• A dedication to continuous improvement and outstanding quality standards.

Join us at Lonza AG and be part of a team that genuinely improves the world through science and innovation!

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.