Supervisor, Quality Assurance Media Operations

United States, Walkersville (Maryland)

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.

The Supervisor, Quality Assurance Media Operations will be responsible for managing Quality Assurance (QA) activities and staff associated with documentation and product release policies and procedures. Device History Record (DHR) and Master Batch Record (MBR) review, clearing and disposition of products and raw materials. Review and approval of deviations, investigations, CAPA, and Out of Specification Investigations for Lonza Walkersville. The individual must demonstrate operational excellence values and effectively collaborate with other members of QA to ensure the products and services are compliant with cGMP expectations of the applicable regulatory authority.

Key Responsibilities:

  • Oversight of QA personnel as well as participate in the observation of critical manufacturing process steps, clean room behavior and adherence to defined process parameters by performing walk-throughs of Production and support areas.
  • Ability to guide and address unforeseen events during the production activities on the floor to ensure product quality is maintained and production activities are resumed.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Manage and maintain site compliance to the approved Quality Systems, applicable quality regulations, guidance documents, industry standards, and customer expectations.
  • Reviews and approved deviations, change controls and CAPAs.
  • Manage and oversee the personnel responsible for raw material, intermediate, and finished product release.
  • Manages and oversee the personnel responsible for quality on the floor.
  • Hire, train, and evaluate department personnel.  Conduct employee performance evaluations

Key Requirements:

  • Bachelor’s degree in life sciences preferred.
  • Related QA/cGMP experience with a regulated industry (pharmaceutical or biopharmaceutical preferred).
  • Prior experience with cGMP requirements of FDA and EMA.
  • Prior experience with ISO 9001 and 13485 requirements preferred.
  • Written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
  • Prior experience with Therapeutic Cell Bioprocessing and/or Device processing preferred.
  • Prior experience with and application of Operational Excellence and Project Management tools.
  • Strong diplomacy, negotiation, and written and oral communication skills.

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: R26571