Manager, QA Compliance at Lonza Inc. in Portsmouth, New Hampshire

Job Description:

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.

Join Lonza AG, where your demonstrated expertise in Quality Assurance and adherence to GMP will be the foundation of our success! As a Manager, QA Compliance, based in New Hampshire, you will have a meaningful role in upholding our extraordinary standards. This opportunity is outstanding because it enables you to orchestrate ambitious initiatives that directly influence the quality and efficiency of our life-saving products!

Key responsibilities:

• Maintain and monitor processes related to Document Management, Change Control, Deviations, CAPA Management, Inspections, and Audits.




• Serve as the primary Subject Matter Expert (SME) for Quality and GMP compliance issues.




• Conduct regular assessments of the Quality System's compliance and efficiency, reporting findings to leadership through forums such as the quality council.




• Collaborate with collaborators to implement critical initiatives and cultivate a culture of quality awareness and GMP compliance.




• Coordinate GMP activities ensuring manufacturing systems and controls meet Global Quality standards and regulatory requirements.




• Coordinate change control, deviation, and CAPA lifecycle, including batch record review and lot release, and validation activities.




• Ensure objectives align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.




• Partner with internal customers to assess and resolve higher-risk issues with Change Controls, Deviations, CAPA, and Investigations.




• Attend and/or co-chair Change Control Committee, Deviations Review Board, and CAPA Board meetings.




• Lead and supervise Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.




• Identify and drive continuous improvement initiatives to establish an effective Quality Management System in alignment with cGMP guidelines.




• Coordinate and lead all aspects of gap and risk assessments to address compliance issues.




• Support Audits and Inspections, acting as SME for Compliance and Quality Records.




• Provide direction and support for QA staff and customers, acting as a point of escalation.




• Conduct team meetings to review objectives, provide support, and resolve issues.




• Participate in the hiring process, provide performance feedback, coach, mentor, and support career development.




• Develop team goals, supervise progress, and ensure continuous improvement.




• Perform other duties as assigned.

Key requirements:

• Bachelor’s degree required; Master’s degree preferred.




• 5-10 years of experience in Quality Assurance and GMP compliance.




• Demonstrated expertise in maintaining and monitoring quality systems.




• Outstanding ability to collaborate with cross-functional teams and internal collaborators.




• Proven track record of successfully implementing critical initiatives.




• Strong leadership skills with experience in team management.




• Excellent communication and problem-solving abilities.




• Ability to thrive in a fast-paced, ambitious environment centered around continuous improvement.

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.