Manager, Internal Quality Operations - Lexington, MA
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.
Lonza’s Lexington, MA site has an exceptional opportunity for a Manager, Internal Quality Operations. This individual is responsible for working through all aspects of Quality Assurance as it relates to GMP operations at the Lexington, MA site. Responsible for day to day quality oversight of activities, deviation management and change control related to drug substance and drug product manufacturing and batch release. Responsible for working cross functionally to finalize and continuously improve upon the Quality System for internal manufacturing and product release with respect to Good Manufacturing Practices (GMP). Individual will act as the primary Quality Assurance point of contact for Internal GMP operational activities and Key Account Quality Manager for selected customers and lead and develop a growing Quality Operations team.
- Maintain and improve upon Quality Systems to ensure compliance with FDA/EMA/ICH and other applicable regulations, operational effectiveness in accordance with company standards with respect to GMP Operations. This includes but is not limited to materials management, GMP drug substance and drug product operational and compliance support, and batch release.
- Provide appropriate quality oversight of document generation and execution to ensure consistency, compliance and operational excellence in all areas identified above
- Responsible for promoting a strong culture of quality awareness within GMP Manufacturing Operations.
- Establish and support development phase GMP compliance and quality oversight for Drug Product and Drug Substance manufacture, testing, and stability; review and assess internal production and testing methods, specifications, validations, reference materials and test results.
- Act as Quality Lead to support Tech Transfer activities into the Lexington Site.
- Act as Key Account Quality Manager for selected customers. As such, will manage Quality relationships with clients to resolve discrepancies and noncompliance events.
- Ensure appropriate quality assessment of quality system documents including Change Controls, Deviations, CAPAs, Investigations/OOS, where impactful to GMP Operations.
- Bachelors (Master’s Degree is preferred) in a Life Sciences or related science discipline.
- Preferred experience with complex biologics, phase 1-3 stage product development and manufacturing of sterile products. Technical knowledge of analytical method qualification, process validation and establishing product specifications are a plus
- Experience with internal manufacturing and testing operations
- Experience in working in compliance with US, EU and ICH GMP requirements
- Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
- Excellent oral and written communication skills, with an ability to shape, frame and present to diverse internal and external audiences.
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
- Proven organizational and leadership skills to mentor and develop cross-functional team to achieve Company goals. Demonstrated ability to effectively lead professional staff
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.