Manager, Quality Assurance

United States, Greenwood (South Carolina)

Quality Assurance Manager

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.

In  accordance  with  goals,  a  job  standard,  and  oral  instructions,  the  QA Manager is responsible to direct and coordinate the quality system efforts within  the  Lonza Greenwood  hard  capsule  facility.  The  leader must   ensure   dedicated   customer   and   process   improvement   focus.  Consistently recognize opportunities for improvement in the overall quality based on external and internal quality indicators. Communicate directly with management in regards to quality, validation, document control, in-process sampling  and  batch  record  requirements.    Must  be  able  to  exercise judgment,  meet  deadlines,  and  be  a  strong  team  leader.    Ability  to  work under stress and pressure, and maintain a patient and friendly attitude.

Key responsibilities:

  • Promote and establish a safe work environment for Quality colleagues.
  • Ensure compliance to cGMP procedures and regulations.
  • Design and improve quality systems for multiple departments ranging from raw material, operations, customer service to product distribution.
  • Establish and maintain compliance to Quality Management system in accordance to global and regulatory requirements.
  • Direct validation objectives within the Greenwood Capsugel plant.  Keep activities in line with FDA, ISO and Capsugel requirements. 
  • Lead validation efforts on Greenwood projects, processes and systems
  • Support continuous improvement strategy by leading quality improvement teams though lean six sigma methodology.
  • Leader and responsible for all batch record approvals and in-process sampling/auditing.
  • Assure all quality activities are performed in compliance with approved procedures as well as current regulatory requirements and guidelines
  • Ensure all training and document control compliance for the Greenwood site – hard capsule facility.
  • Ensure accuracy and compliance for all quality systems to include Deviations, Risk Assessments, CAPA and change control.
  • Perform other duties as assigned

Key requirements:

  • Bachelor’s degree in Engineering, Engineering Technologies, Industrial Management, or Business Administration.
  • Advanced experience in capsule manufacturing preferred.
  • Knowledge of validation, auditing, cGMPs, Quality Assurance techniques, FDA and ISO requirements, and production.
  • Must be able to lead a team.
  • Advanced computer skills to include MS office products, Teams, SAP, and MES applications required.
  • Excellent communication skills, both verbal and written. 
  • Must be able to interact with colleagues at all levels of the business.
  • Must be able to make timely and sound business decisions.

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: R38667