Quality Assurance Manager, Site Operations (Biotech)

Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents.

Lonza AG is presenting an outstanding opportunity for a skilled individual to join the team as a Quality Assurance Manager, Site Operations Manager in New Hampshire, USA. This role is uniquely positioned to ensure magnificent quality oversight across our site operations, giving to Lonza's premier reputation in life sciences. Join our daring team and play a substantial role in maintaining and improving our detailed standards of quality and compliance.

Key responsibilities:

• Lead a team of QA Compliance/Operations Specialists, providing general direction and acting as a point of escalation for QA staff and customers.
• Ensure objectives are met and expectations align closely with Lonza SOPs and regulatory requirements.
• Review and revise the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
• Partner with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher-risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Independently review and approve documents within a Document Management System, such as SOPs, Work Instructions, Forms & Checklists, and other necessary documents.
• Review and approve electronic and/or paper Validation/Qualification documents, including Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems.
• Lead and track Key Performance Indicating Quality Metrics, including batch release information for senior site management.
• Conduct regularly scheduled team meetings and one-on-one meetings with staff to review objectives, provide support and feedback, and resolve issues.
• Participate in the hiring process, provide performance feedback, coach, mentor, and support career development.
• Support Regulatory and Customer Audits as needed.
• Identify and implement improvements to quality processes.

Key requirements:

• Bachelor's Degree or equivalent experience with at least 3 years of exposure to a GMP regulated environment.
• Consistent track record in leading sophisticated quality processes and facilitating cross-functional collaboration.
• Outstanding problem-solving and analytical skills with strict attention to detail.
• Excellent written and verbal communication skills.
• Ability to optimally complete and lead multiple projects at the same time.
• Proven capability in root cause analysis and implementing corrective and preventive actions.
• Adaptability to a complex business environment and consistent delivery of high-quality results.

Join us at Lonza AG and be part of a team where your contributions are valued, and your career ambitions can truly flourish.

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.