Quality Control Senior Manager

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 Walkersville  is currently recruiting for a Quality Control, Senior Manager. This role will assist the Head of Quality Support with oversight of the QC Testing Services Unit including strategic direction and budget development. Provides leadership and directs all work activities for a Functional Area (i.e. Cell Biology, Microbiology, Endotoxin or Molecular Testing). Manages the lab through lower level Managers and Supervisors to ensure that customer requirements are met and Standard Operating Procedures are followed.

Key responsibilities:

  • Assist Head of Quality Support with strategic planning and daily operations of QC Testing Services including budget development and management
  • Direct management for testing laboratories that conduct final release testing for research bioproducts and early development through late stage clinical trial cell therapy products.
  • Participate in technology transfer of customer documentation and testing protocols. Participate in client meetings. Participate in compliance audits.
  • Oversee company’s test sample receipt laboratory that tracks all internal QC testing, external testing services and contract manufacturing testing projects.
  • Assist Department Managers / Supervisors with out of specification investigations, technical troubleshooting / problems solving, staff recruitment and career development.
  • Develop and maintain effective working relationships with key internal / external customers.
  • Assist with implementation of department test methods, write and revise bills of materials, prepare monthly reports and participate in regulatory audits.

Key requirements:

  • A minimum of a Bachelor’s degree in Lifesciences or related discipline is required, Master’s degree  and/or Master’s or PhD preferred.
  • Substantial years of experience within Quality Control and support is required.
  • Knowledge of biology, microbiology, biosafety testing for cell therapy products.
  • Experience in a cGMP (Biotech/Pharmaceutical industry).
  • Experience with Contract Manufacturing environment.
  • Time Management, facilitation skills, project management skills, computer software skills.
  • Experience in Project Management, Budget Preparation and Technical Writing.
  • Diplomacy, negotiation skills, written and oral communication, independent work skills, strong work ethic.

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: R36490