Lead, Quality Systems

United States, Greenwood (South Carolina)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 support to the Greenwood Ingredients operations for oversight of dietary supplements and food regulations. This position will provide the primary administration, reporting and oversight of major quality systems for the ingredient portfolio.

Key responsibilities:

  • Administration of Quality Systems to include: Master Data, Deviations, Complaints, Change Control, Internal Auditing, Supplier Auditing, HARPC (Hazard Analysis and Risk-Based Preventive Controls) and CAPA (Corrective and preventive action).
  • Conduct and manage training compliance to include GMP.
  • Host audits and respond to audit findings.
  • Responsible for compiling and reporting monthly metrics related to quality systems.
  • Assist Quality Manager in developing annual quality plan and quality summit.
  • Oversight of Policy/SOP (Standard Operating Procedures)/SOI (Standard Operating Instructions)/WI (Work Instructions) compliance.
  • Development of procedures and controls in support of the Quality Management System.
  • Identify and implement potential improvement projects, as appropriate.
  • Final Approval/Disposition of batch records and ensure compliance to master batch record. Manage Product Specification Sheet and Certificate of Analysis approval and compliance.

Key requirements:

  • Bachelor’s degree, preferably in Business, Engineering, or Science related field.
  • Experience in a QA (Quality Assurance)/QC (Quality Control) position in a regulated industry.
  • Demonstrated ability to lead and train other associates.
  • Dietary supplement, food or pharmaceutical experience
  • Experience with implementation of quality systems
  • Working knowledge of 21 CFR 111 (Code of Federal Regulations) and 21 CFR 117
  • Experience with customer and regulatory audits/inspections

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: R21971