Associate Director, QC

United States, Greenwood (South Carolina)

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.

The Associate Director of Quality Control will be responsible for the management and operation of the Quality Control functions, and laboratories including Chemistry, Microbiology, Global Stability and Color Development.  Responsible for overseeing laboratory colleagues who are responsible for testing requirements and associated activities of all raw materials and finished products.  Ensures laboratory practices are aligned with established company quality standards and regulatory guidelines.

Key responsibilities:

  • Manages colleagues performing various test procedures to determine the quality, uniformity and stability of raw materials and finished products in compliance with company specifications, quality standards and government regulations in support of the hard capsule business when deemed necessary for continued operational excellence.
  • Assures compliance with company standards and specifications, government regulations (compliance with latest compendia requirements), as well as current Good Manufacturing Practices (cGMP’s) and current Good Laboratory Practices (cGLP’s).
  • Develop and maintain a strong organizational structure within the laboratories by recruiting skilled personnel, providing internal cross-training, external training opportunities, and developing staff in all aspects of the business.  Manages colleague performance and development and ensures accurate curriculums are established for all lab colleagues.
  • Administers and monitors department operating budgets.
  • Coordinates testing support as needed for all Capsugel affiliates globally including analytical evaluations as well as stability studies.
  • Provides resources to support troubleshooting internally to ensure process continuity and product integrity.
  • Manages investigations around customer complaints and work directly with customers to provide solution to issues with testing methodology.
  • Manage continuous improvement projects and implement new innovative solutions to improve current processes.
  • Develop and implement Key Performance Indicators to monitor the efficiency and productivity of the laboratory performance.
  • Provide R&D support for the introduction of new raw materials and new product launches.
  • Reviews and maintains documentation and records for accuracy and compliance.
  • Manages 3rd party testing schedule compliance and quality agreements.
  • Must be able to work 40 hours a week, which may include weekends, holidays, etc.
  • Must be able to work additional hours/days as business needs dictate
  • Attendance in the plant site is considered an essential function.

Key requirements:

  • BS Degree in Science Chemistry or equivalent field of study
  • Masters Degree in Science/Chemistry preferred.
  • Substantial experience in the management and operation of the Quality Control functions and laboratories.
  • Experience with manufacturing highly desired
  • Knowledge of regulatory guidelines (IPEC, USP, 21 CFR, ICH, etc.)
  • Strong proficiency with word processing, database and statistical computer software
  • Strong and professional communication skills (written and verbal)
  • Demonstrated proficiency with standard and advanced laboratory equipment.
  • Must be highly organized, detail oriented and able to manage multiple projects.

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: R54587