Manager, Quality Assurance Operations - LSA (Biotech)
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, a global leader in life sciences, as our new Manager, Quality Assurance in New Hampshire! This role is uniquely positioned to manage a team with sophisticated strengths, ensuring detailed execution of quality standards in our daring operations. You will play a relevant role in maintaining the outstanding quality of our products, which challenges the credible level. This is your chance to resolve and efficiently implement quality strategies that will have a lasting impact!
Key responsibilities:
Provide mentorship and leadership for Quality Associates coordinating on-the-floor activities during batch execution.
Direct Quality Associates or individuals with equivalent experience in reviewing GMP documentation generated throughout the manufacturing process.
Lead changeovers, coordinate shutdowns, and conduct daily on-the-floor walkthroughs to ensure compliance with quality standards.
Actively work with Manufacturing Operations, Quality Control (QC), Facilities Engineering (FE), and other internal collaborators to ensure adherence to quality standards.
Participate in the Document Review Board (DRB) and assess quality records to ensure compliance with Lonza standards.
Work closely with the QA Project Manager and various teams to meet project timelines and uphold expectations for product quality and GMP compliance.
Work well with internal and external customers as the Quality Subject Matter Expert for customer-related quality issues.
Key requirements:
Bachelor's Degree required or equivalent experience; Master's degree preferred.
3-5 years in Quality Assurance; sophisticated level of 5-10 years preferred.
Confirmed experience in Quality Leadership within the pharmaceutical industry.
Experience with cell therapy and/or gene therapy is helpful but not crucial.
Good foundation in GMP application in drug substance or drug product manufacturing.
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.
