QA Validation Manager, Computer Systems

United States, Portsmouth (New Hampshire)

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 Lonza QA Computer Systems Validation (CSV) group completes a variety of tasks relating to the validation of computerized systems and software utilized in the GMP manufacture of biopharmaceuticals. The QA Validation CSV Manager is instrumental in achieving this goal through development of team goals, daily management of team assignments and ensuring continuous application of the strategy defined in the Computerized Systems Validation Master Plan.

Key responsibilities:

  • Managing and planning the work of the computerized system validation team.  Assessing workload and managing resource deployment to achieve validation goals.  Responsible for managing and tracking execution of validation activities versus project timelines.  Provide guidance and resource planning for both routine operations and capital project validation activities.
  • Identifies efficiencies and process improvements in the CSV program approach. Works to apply lessons learned and stay informed of industry regulatory changes as it applies to computer systems validation.
  • Develop and maintain computer validation master plan, validation protocols, and project plans.  Review and approve completed protocols/reports for completeness, cGMP compliance and acceptability of data as needed.
  • Develop, train, coach and mentor direct reports on validation team in areas of technical expertise, task management and leadership.
  • Presents and defends the computer systems validation program and acceptance criteria to Clients and Regulators.
  • Reviews and revises the Validation Master Plan as necessary to ensure GMP compliance with applicable regulations, guidelines and best practices.
  • Establishes/Maintains Validation Maintenance program for the computer systems validation group.

Key requirements:

  • Bachelor’s degree, preferred area of study in science or technical discipline.
  • Substantial experience in a validation function, preferably within pharmaceutical, life sciences or biotechnology environment.
  • Background in automation or computer science desired.
  • Excellent technical writing skills and ability to document all work in a meticulous, accurate, and timely manner. 
  • Excellent written and verbal communication skills and ability to work interdepartmentally in an effective manner to carry out daily duties. 
  • Prior management or supervision experience required, effective coaching and team leadership skills.
  • Excellent organizational and time management skills.
  • System Matter Expert (SME) for CSV Program.
  • Provides training and mentoring to the Validation team as well as other departments as necessary to accomplish the goals of the Validation program

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: R31198