Quality Assurance Project Manager II, Operations (Biotech)
Today, Lonza is a global leader in life sciences operating across three 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 us at Lonza AG in the heart of New Hampshire, USA, as we continue our daring journey towards excellence in life sciences! We are currently seeking a Quality Assurance Project Manager 2- Operations (QA PM II) to be a key player in our operations. This role is uniquely positioned to directly influence and improve our quality assurance processes, ensuring detailed execution and elite outcomes.
Key responsibilities:
- Partner with internal functional areas as part of the change control process
- Review and approve investigation reports for assigned customers; ensure actions prevent recurrence.
- Interact with internal and external customers as part of Joint and Internal project teams serving as the Quality Subject Matter Expert for any customer-related quality issues
- Track and present customer metrics
- Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures
- Review and approve various product-specific documents such as Quality Agreements, Product Quality Reviews, Master Batch Records, etc.
- Support customer audits
- Perform other duties as assigned
Key requirements:
- A Bachelor's degree in a related field or equivalent experience
- A minimum of 10 years of validated experience in QA project management within the life sciences industry
- Expertise in handling change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and Quality Agreements
- Proven capability to effectively collaborate with both internal and external collaborators to identify and implement standard methodologies
- Strong leadership and mentorship skills with a track record of guiding teams to compete at the highest levels
- Outstanding attention to detail and the ability to work independently with minimal direction
- Excellent communication and interpersonal skills to ensure all customer service expectations are successfully met.
This is your opportunity to join a team that is dedicated to making a meaningful impact in the field of life sciences. Come be part of our journey and help craft the future of quality assurance at Lonza AG!
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.
