Quality Lead

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 Quality Lead colleague will provide support to the Greenwood DFS operations for oversight of dietary supplements. This position will provide leadership in the primary administration, reporting and oversight of major quality systems and will be responsible for QA and customer relationships for key customers for the DFS business.

Key responsibilities:

  • Responsible for managing the total quality relationship with key customers as defined by the business.
  • Manage customer audits and regulatory inspections.
  • Manage the Quality Coordinator and Sr. QA Coordinator roles within the DFS quality organization.
  • Administration of core Quality Systems to include Deviations, Change Control and CAPAs.
  • Responsible for compiling and reporting monthly metrics related to quality systems.
  • Maintain and report monthly KPIs.
  • Assist QA Manager in developing annual quality plan.
  • Serve as the chairman of the Quality Council team for DFS.
  • Oversight of periodic SOP/SOI/WI Reviews
  • Write SOI’s / WI’s where applicable.
  • Identify and implement potential improvement projects, as appropriate.
  • Coordinate and oversee annual cGMP training as necessary.
  • Development of procedures and controls in support of the Quality Management System
  • Act as the sanitation supervisor for the DFS site.
  • Perform risk assessment in support of Quality decision making
  • Responsible for reviewing, approving, and managing Quality Documents related to Master Batch Records.  Responsible for approving Packaging Specifications, Purchasing Specifications and other related quality documents.
  • Assist in approving or rejecting raw materials and finished goods when needed.
  • Assist in Issuing, reviewing, and approving production batch records when needed.
  • Perform second review and disposition of batch records as necessary
  • Must be able to work the appropriate shift required for this position.
  • Must be able to work overtime when needed which could include weekends or holidays as business needs dictate.
  • Attendance on plant site/office site is essential.
  • Serve as back-up for DFS QA Coordinator.
  • Serve as back-up for scheduling and maintaining contract calibration services.
  • Perform other duties as assigned.

Key requirements:

  • Bachelor’s degree in business, science, related or technical field.
  • Advanced statistical training and ASQ certification preferred.
  • Must be computer literate and be able to use Word, Excel, PowerPoint, and other programs.
  • Must be familiar with SAP functionality and basic use.
  • Must have excellent written and verbal communications skills and be able to communicate to all levels of management effectively.
  • Must be able to represent company effectively with customers in written and verbal communication.
  • Must be able to work effectively in a team environment.

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: R56414