Quality Head, Cell & Gene Technology

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 Site Quality Head CGT will lead the Quality organization (QA & QC) and will assure the site remains under control with respect to GMP, collaborating with Operations to solve quality issues. Accomplishes corporate business objectives by developing site quality systems and enforcing Regulatory compliance. Responsible for providing the strategic leadership and management for the Site`s Quality organization. Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team. Ensures alignment with customer needs and linkage with the overall Quality and business strategies. 

Key responsibilities:

  • Acts as Key Account Quality Manager for selected customers
  • Leads & supports Audits & Regulatory Inspections at the Site
  • Leads and directs staff in both QA and QC and ensures their development
  • Develops compliance related manufacturing and process controls and improves quality systems
  • Holds responsibility for Quality budget and driving Operational Excellence
  • Member of the Site Leadership team

Key requirements:

  • BS degree in a Life Sciences, Engineering or Quality Management or related science discipline
  • Highly experienced in GMP manufacturing and Quality Management of products regulated by FDA CBER or CDER or EMA
  • Proven experience in senior leadership positions
  • Must have prior aseptic processing experience
  • Proven experience implementing CI initiatives to drive Quality programs and ensure maximum productivity.  Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
  • Past experience developing, implementing and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
  • Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.
  • Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza’s long-term objectives.
  • Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
  • Represent the Lonza on quality and cGMP compliance issues that are specific to the site.
  • Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested.

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: R54165