QA Validation Lead

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.

QA Validation Lead is responsible for oversight of validation activities on site ensuring compliance with current regulatory requirements.

Key responsibilities:

  • Provides QA ownership and oversight of the Lonza Hayward Pharmaceutical Quality System (PQS).
  • Ensure GROUP PQS is implemented on site and the on-going generation and maintenance of SOPs and controlled documents.
  • Responsible for overall validation strategy of manufacturing equipment/utilities/ and GxP computerized systems.
  • Manage the requalification program to ensure existing systems remained in a validated state and demonstrated continuous control.
  • Interface with Validation team to develop strategy, enhance process and share best practices.
  • Responsible for investigating validation deviations and ensure Corrective and Preventative Actions (CAPAs) are appropriate and closed.
  • Defend validation strategy during audits and assess the adequacy of responses to the audit findings.

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: R35824