Associate Director, Head of Quality Compliance

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 Quality team is looking for an energetic, team player with the agility to meet changing priorities and a roll-up-your-sleeves approach to work.  The successful candidate will be someone who drives to meet/exceed KPIs while at the same time enables an atmosphere of learning and growth.

The Associate Director, Head of Quality Compliance will lead a team of (4) direct reports whose mission is working with people effectively to ensure 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).  The key stakeholders that the Associate Director will interact with will be Quality Assurance, Site Leadership and the Manufacturing team. 

Key responsibilities:

  • Own the audit and inspection readiness program
  • Plan and coordinate internal and external audit and inspection schedules
  • Act as primary host for all audits and inspections
  • Lead completion and resolution of audit and inspection findings, including relevant communications to internal and external partners
  • Own and actively manage the site risks register, including monthly reporting to the Quality council
  • Provide KPI reporting and execute action plans to address opportunities for improvement
  • Coordinate and deliver audit and inspection related training
  • Provide coaching and development to direct reports to enable an atmosphere of learning and growth

Key Requirements:

  • Bachelor’s degree
  • Highly experienced in Quality Assurance/CAPA Management
  • 5 or more years of direct audit experience with FDA/EMA/ISO regulations
  • GMP compliance expertise 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 skillsMicrosoft Office and database management; Trackwise (eQMS)

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: R44147
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