Associate Director, Quality Assurance (Bioscience)

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.

We are seeking an experienced Quality Assurance professional with management experience to join the Bioscience team in Walkersville, MD.  You will be  working in a fast-paced, highly regulated environment with a fabulous group of QA team members.  Additionally, you will  be responsible  for overseeing and directing all aspects of quality assurance and compliance with applicable regulatory requirements for media related products.  The ideal person for this role will have experience in aseptic filling of biologics,  through knowledge of FDA regulations and will be a strong collaborator/leader with excellent communication skills. 

See what we are all about: Lonza Bioscience | Lonza

Key responsibilities:

  • Directs staff of QA media operations specialists that review and approve device master records, batch records, testing, and aseptic operations
  • Managing QA team to comply with internal requirements, applicable FDA regulations including ISO and 21CFR820
  • Participate in the development of actions plans to correct deficiencies and improve processes and provide direction for complex deviations and complain investigations
  • Leads/supports regulatory or client audits as SME for aseptic media
  • Develop and approve cGMP documents, ensuring process efficiency
  • Maintenance of quality systems and cGMP compliance for the business

Key requirements:

  • Bachelor's degree; Life Sciences preferred
  • At least 10 years of GMP experience in aseptic filling of biologics  or equivalent
  • Significant management experience with at least 5 years in a QA supervisory or management role
  • GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and other regulatory requirements for US and EU
  • Working Knowledge of endotoxin testing preferred
  • Excellent communication skills
  • Ability to multitask and adequate sense of urgency a must

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: R48762