Quality Systems Lead (Hard Capsules) at US26 Lonza Greenwood LLC in Greenwood, South Carolina

Job Description:

Quality Systems Lead

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 Systems Lead will provide compliance leadership to the Greenwood hard capsule operations, DFS and Ingredients for oversight of food and IPEC regulations. This position will provide lead the SAP, Salesforce, customer and operations specifications to ensure compliance to global regulatory requirements. Manage the  oversight of major quality systems for the hard capsule portfolio.

Key responsibilities:

• Lead and ensure compliance to Quality Systems to include: Master Data, Product specifications, Deviations, Change Control, FDA regulations, CAPA and Certificate of Analysis.


• Lead for SAP material master data to include all capsule attributes and recipe compliance.


• Responsible for compiling and reporting monthly metrics related to quality systems.


• Coordinate DMS for Greenwood site (hard capsules, DFS, Ingredients)


• Oversight of Policy/SOP/SOI/WI compliance. Development of procedures and controls in support of the Quality Management System.


• Manage Product Specification Sheet and Certificate of Analysis approval and compliance.


• Participate in Corporate, Customer, and Certification plant audits.


• Ensure audit readiness by conducting internal audits for HC (Hard Capsule)


• Lead with new hire orientation duties regarding LMS and DMS.


• Manage and conduct updates to SAP, CMO Notes, and Salseforce.com in support of new products


• Ensure compliance metrics are achieved in regards to LMS, DMS, and SAP master data compliance


• Lead teams as needed regarding LMS, DMS, and SAP master data compliance


• Support continuous improvement projects for business strategy


• Assist Quality Manager in developing annual quality plan.


• Identify and implement potential improvement projects, as appropriate.


• Must be able to work the appropriate shift required for this position.


• Must be able to work overtime – more than 40 hours per week or 8 hours per day.


• Perform other duties as assigned.

Key requirements:

• Bachelors of Science in Business, Engineering, or Science-related field.


• Experience in Quality-related field required.


• Computer skills to include MS office products required.


• Excellent communication skills, both verbal and written. 


• Must be able to interact with colleagues at all levels of the business.


• PCQI and/or FSVPQI preferred

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.