Head of Validation

United States, 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.

The Head of Validation leads all aspects of QA Validation for Lonza Portsmouth’s mammalian bulk drug substance contract manufacturing facilities. In this role, you will ensure that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements regarding qualification and validation. This role is accountable for validation strategies, programs, continuous improvement and team leadership for equipment and utilities qualification/validation, process equipment cleaning validation, and computer systems validation.

Key Accountabilities:

  • Develop and lead the overall quality strategy for QA Validation.
  • Partner with Manufacturing Asset Heads, QA Heads and Senior leadership Team to ensure alignment in approach with execution of QA validation programs.
  • Provide QA oversight to the Engineering Department.
  • Ensures that the site is “inspection ready” at all times in regards to validation.
  • Interface between capital project teams and site validation teams.
  • Ensures that validation component of capital projects is completed on schedule and within budget.
  • Build and maintain expertise in qualification/validation within the QA Validation teams, ensuring development of Validation managers and staff.
  • Maintain cross-site and industry connections to ensure Lonza’s validation programs remain at the forefront of the Lonza network and the biopharma industry.

Key Requirements:

  • Bachelor’s Degree required. Preferred area of study in life science or engineer.
  • Significant experience in biopharmaceutical manufacturing.
  • Substantial experience in Quality Operations or Quality systems GMP environment.  
  • Detailed knowledge and understanding of validation programs and regulatory requirements, biopharmaceutical bulk drug substance manufacturing and quality operations.
  • Strong knowledge in the application of cGMP requirements, biomanufacturing process and relevant manufacturing equipment.
  • Understanding of facility design requirements and validation programs to show the design as delivered is fit for use.
  • Understanding of validation /qualification principles, industry practices and standards with ability to apply these to GMP operations.
  • Demonstrated ability to lead teams of diverse skill sets, make sound decisions regarding evaluation of validation programs and ability to influence at various levels in a cross-functional organization.

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 it is 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: R28641