QC Systems Manager, Quality Control

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 Portsmouth facility is growing. We are looking for professionals to grow with us in our Quality Control (QC) group.
POSITION: QC Systems Manager, Quality Control
JOB LOCATION: 166 Corporate Dr. Portsmouth, NH 03801
DUTIES: Provide strategic, tactical, and objective leadership for computerized system validation team. Directly support QC laboratory operations, biochemistry, microbiology, stability, environmental monitoring and technical transfer team. Provide general leadership, guide and support to ensure staff is meeting QC objectives and deliverables on-time and in-full. Support overflow of needed tasks to ensure deliverables are managed and met, and track key performance indicator metric for Quality Control. Manage teams that complete analytical instrument and software validation deliverables. Write GMP procedures, validate documents and executes test scripts. Manage the team that administer QC enterprise software application: ELN, LIMS, and CDS. Validate templates in QC software applications, ELN, LIMS and CDS and perform applications troubleshooting in local computer systems. Implement analytical instrument engineering controls for QC laboratories. Manage QC computer system validation, Empower, LIMS teams. Approve and own technical documents in Document Management System (DMS). Perform all aspects of QMS processes: change control, deviations, CAPAs, tasks write out, review, asses, and/or approve change controls for QC laboratories. Manage program performing analytical instrument qualifications. Manage computerized systems' full life cycle validation from the planning phase to review phase. Challenge the status Quo and identify team improvement opportunities. Participate as an SME during regulatory and customer audits and inspections. Control and plan tasks/projects while adhering to quality and safety. Ensure funding for internal QC laboratory purchases are approved for spending. Oversee two Project manager Lv 3, one Project Manager, one QC Systems Validation senior lead, one QC Lead, and one QC systems Specialist.
MINIMUM REQUIREMENTS: Requires a Master's degree, or foreign equivalent degree, in Pharmaceutical Engineering and 3 years of experience in the job offered or 3 years of experience in a related occupation providing strategic, tactical, and objective leadership for computerized system validation team; directly supporting QC laboratory operations, biochemistry, microbiology, stability, environmental monitoring and technical transfer team; implementing analytical instrument engineering controls for QC laboratories; managing QC computer system validation team; performing all aspects of QMS processes: change control, deviations, CAPAs, tasks records, review, asses, and/or approve change controls for QC laboratories; managing the full validation life cycle of computerized systems, from planning phase to review phase; participating as an SME during regulatory and customer audits and inspections; directing, controlling and planning tasks/projects while adhering to quality and safety; performing assigned, complex tasks and ability to interpret data; maintaining control of meetings.
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.