Quality Compliance Manager (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.

Our Walkersville, MD team seeks outstanding candidates for a Quality Compliance Manager to support and partner with the  Associate Director of Quality Compliance in ensuring plant-wide compliance to all applicable cGMP regulatory standards and execution of all phases of audits and inspections (internal, supplier, customer, 3rd party registrar audits, ISO and FDA inspections).  In this role, you will lead a team of (2) direct reports and be an integral part of developing/interpreting metrics and audit success.

Key responsibilities:

  • Lead and support audit and inspection readiness activities
  • Lead and support activities needed to effectively execute internal and external audit and inspections
  • Act as host for all audits and inspections
  • Lead and support completion and resolution of audit and inspection findings, including relevant communications to internal and external partners;
  • Provide subject matter expertise as needed, to ensure observations are progressed and completed on-time and with sufficient documented evidence
  • Coordinate and deliver audit and inspection related training
  • Provide coaching and development to functional and cross-functional personnel to enable an atmosphere of learning and growth

Key Requirements:

  • Bachelor’s degree
  • Experience with Quality Assurance/CAPA and audit management
  • At least 2 years of direct audit experience with FDA/EMA/ISO regulations
  • Prior supervisory experience a strong plus
  • GMP compliance experience including knowledge of 21CFR210, 211, 820, ISO 9001, 13485
  • 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; Trackwise (eQMS)
  • 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: R44548