Quality Assurance Manager, Compliance (Biotech)

 

Are you seeking a role where you can make a significant impact and lead a team to success? Lonza AG is rapidly growing, and we invite you to be a part of our growth as a Quality Assurance Manager in Compliance! This position offers an outstanding opportunity to develop and implement elite quality processes and drive continuous improvement in a dynamic environment. Join us in New Hampshire, USA, and contribute to our mission of improving lives globally through life sciences.

Key responsibilities:

• Lead a team of QA Compliance Specialists and QA Project Managers, ensuring objectives and deliverables are met on time and in full.
• Act as a point of escalation for QA staff and customers, providing direction and support.
• Ensure alignment of objectives with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Collaborate with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to 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, as well as Site Quality Council and Lot Disposition meetings.
• Manage and track Key Performance Indicating Quality Metrics, including monthly/quarterly deviation trending reports for senior site management.
• Perform Lot Release/Disposition activities.
• Identify and implement improvements to quality processes, promoting a strong culture of quality awareness and GMP compliance.
• Develop team goals, monitor progress, and ensure continuous improvement through regular meetings and feedback.
• Participate in the hiring process, provide performance feedback, and support career development.
• Support Regulatory and Customer Audits as needed.
• Perform other duties as assigned.

Key requirements:

• Bachelor's Degree or equivalent experience.
• Minimum of 5 years of relevant experience in quality assurance, preferably in the life sciences industry.
• Proven leadership skills with the ability to manage and develop a team.
• Strong understanding of GMP compliance and regulatory requirements.
• Outstanding problem-solving abilities and attention to detail.
• Ability to successfully implement improvements and drive projects to completion.
• Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

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.