Quality Control Project Manager

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 in Portsmouth, NH is searching for an experienced Quality Control Project Manager to join our growing QC team.  As our QC Project Manager, you will be responsible for leading projects in the Laboratory Operations team to support the QC Laboratories at the Lonza site in Portsmouth, NH.  Assignments may include administration of local and enterprise software applications (LIMS, Empower. iLAB), coordination of stability studies, validation of computerized systems and instruments, supporting technology transfers and leading internal/external customer meetings.

Key responsibilities: 

  • Author and approver of change controls, specifications, protocols and reports for Raw Materials In-Process, Lot Release and Stability studies.
  • Perform project management: Identifying QC responsibilities, work to be performed and timelines pertaining to area of responsibility.
  • Act as validation SME to complete review/approval of project validation deliverables related to iLAB or other GMP Quality systems utilized within the QC Laboratory.
  • Understand Regulatory requirements and Lonza policies pertaining to the area of responsibility. Ensure applicable QC policies or procedures are appropriate and established and/or revised as necessary.
  • Collaborate and prioritize with QC leaders, other departments, and/or customers to create an achievable work schedule and to ensure agreed upon timelines are met.

Key requirements: 

  • Bachelor or Master’s Degree. Preferred area of study in Microbiology, Biochemistry, Chemistry or Related Science Fields.
  • Significant experience within a regulated cGMP industry.
  • Significant experience working in Quality Control within the Biotech or Pharmaceutical industry.
  • Working knowledge of data integrity principles.
  • Ability to troubleshoot QC software applications.
  • Working knowledge with laboratory systems such as Trackwise, LIMS, Empower, DMS, and electronic notebook.
  • Experience with leading a team.
  • Excellent ability to speak publicly. Able to maintain control of meetings as required. Holds group meetings and delivering clear concise messages.
  • Excellent ability to interpret data. Makes more advanced quality decisions independently and understands when to escalate quality concerns to management.

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. 

Reference: R27785