Quality Manager, GMP Compliance

United States, Hayward (California)

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.

Quality Manager, GMP Compliance

Key Responsibilities:

  • Lead the initiative for reaching commercial readiness at Hayward
  • Lead key improvement initiatives within QA/QC with the objective to reduce complexity and enhance compliance
  • Lead a Quality culture program across the site with the objective of achieving a “Quality beyond Compliance” attitude.
  • Build a strong foundation with customers and support the creation of sustainable relationships.
  • Seek for and realize opportunities to optimize Quality related processes at the sites in with the objective to reduce complexity and as such improve efficiency and compliance. Share learnings with other Lonza sites.
  • Lead selected projects of the ongoing site improvement activities in close collaboration with all Quality functions as well as other departments as appropriate. Reach out to the Lonza network to seek for solutions and share experience in order to drive standardization.
  • Work in close collaboration with Lonza Global and with other Lonza sites to establish common standards in this area.
  • Prepare the site for customer and regulatory inspections.

Key requirements:

  • Proven track record of advanced years’ leadership experience in Manufacturing and Quality
  • University level science degree and/or equivalent qualification
  • Expert knowledge of cGMP requirements in particular in the area of ATMPs. FDA regulatory requirements applicable to FDA regulated products.
  • Expert knowledge of GMP, and FDA regulatory requirements applicable to Biologics
  • Profound knowledge and practical experience in sterile manufacturing
  • Operational excellence experience incl. Lean / Six Sigma
  • Strong analytical skills that include process mapping abilities. Able to structure complex problems and to develop simple solutions

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: R38480