Quality Compliance Lead

United States, Walkersville (Maryland)

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 Bioscience has an exciting opening for a Quality Compliance Lead in Walkersville, MD. This individual will be responsible for supporting the Quality Compliance Manager in ensuring plant-wide compliance to all applicable cGMP regulatory standards.  Responsible for the oversight of the Auditing program, including internal, supplier, customer and 3rd party registrar audits.  Position will also supervise other areas, including, but not limited to:  Audits, Metrics and CAPA programs.

Key responsibilities:

  • Act as primary host for all on-site, customer, and 3rd party registrar audits
  • Plan and coordinate annual internal and supplier audit schedules
  • Primary contact for the completion and resolution of Internal Audit findings
  • Supervise Audits, Metrics and CAPA programs
  • Ensure CAPA’s are implemented, effective and sustained
  • Support Quality Compliance Manager with completing compliance related items
  • Assist with coordination and delivery of GMP, CAPA, TrackWise and Audit training programs, as needed
  • Must be able and willing to work extended hours as business needs dictate, to include weekends and holiday.
  • Perform other duties as assigned.

Key requirements:

  • Bachelor’s degree in a Life Sciences discipline
  • Significant GMP compliance expertise, including knowledge of 21CFR210, 211, 820; the PIC/S Guide to Good Manufacturing Practices Part 1 and 2, or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, ISO 13485:2016
  • Significant Quality Assurance/CAPA Management experience
  • Independent work skills and a strong work ethic
  • Team oriented and promoting of others
  • Ability to interface and communicate directly with customers and regulatory bodies
  • Excellent written and oral communication to include accurate and legible documentation skills
  • Ability to work in a fast-paced environment
  • Ability to effectively manage multiple projects
  • Microsoft Office and database management
  • Organization and Record Keeping

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: R34105