QA Risk Management Professional

Portsmouth, New Hampshire

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.

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.

The Quality Risk Management Specialist is responsible for assisting with management and continuous improvement of the Quality Risk Management Program for the Portsmouth facility according to International Conference on Hormonisation (ICH) Q9 and other applicable regulatory guidance. The Quality Risk Management Specialist must effectively work with departments to provide training, technical support and expertise with Quality Risk Management principles and application.

Key responsibilities:

  • Work with Lonza departments to provide technical support and expertise with the Quality Risk Management Program. 
  • Provide support in all aspects of risk management (planning activities, tool selection/application, facilitation, and consultation).
  • Work with department(s) to understand their project/Quality Risk Management requirements and assist with risk management solution
  • Assist with Quality Risk Management integration (departmental case studies)
  • Support Global initiatives where Quality Risk Management support is required.
  • Reflect on executed risk assessment activities to optimize future assessment activities/projects.
  • Select/adapt Quality Risk Management tools to fit departmental Quality Risk Management requirements that is defendable (audit and inspection)
  • Identify and evaluate advanced tools for application at the site Hazardous Analysis Critical Control Points (HACCP) and establish and deliver training material.
  • Review Quality Risk Management reports where facilitated and/or support is required to comply with Quality Risk Management procedure/program
  • Assist with the management and continuous improvement of the Quality Risk Management program including creation of Quality Risk Management training material and delivery to personnel.
  • Conduct monthly general Quality Risk Management facility training.
  • Maintain established training material and establish/deliver new training modules for the Quality Risk Management program.
  • Defend Quality Risk Management Program during internal and external audits
  • Perform other duties as assigned.

Key requirements:

  • Bachelors Degree or equivalent work experience in the Sciences
  • Advanced Years of experience in a Good Manufacturing Practices (GMP) environment with a specific focus on Quality Risk Management and application/use of Quality Risk Management tools
  • Prefer Yellow/Green/Black Belt
  • Prefer American Society for Quality (ASQ) Certification  

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: R18749