Quality Head, 20K

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 incumbent leads all aspects of QA operations for a Commercial GMP mammalian manufacturing asset and ensures that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements. In addition, this role will liaise with the customer on a regular basis and participate directly in Joint Quality Steering Committees to ensure that QA and compliance activities meet their expectations. The incumbent typically has several QA Managers/Supervisors as direct reports and is responsible for overseeing change control, deviation investigation and CAPA lifecycle, GMP compliance, on the floor operational support, batch record review and lot release, review and approval of technical documentation as well as oversight of all validation activities in support of manufacturing operations within the asset. This role is a member of the Senior Quality organization and participates in decisions and escalations at the site.  

Key responsibilities:

  • Develop and lead the overall quality strategy within the asset.  Partner with Site Quality Head, Asset Heads and Sr. QA Managers to ensure alignment of Manufacturing and support functions and approach in executing the strategic goals of the site.
  • Collaborate with key customers on quality strategy and Quality System execution.
  • Serve on joint Lonza-customer teams. Act as the lead SME for significant quality/GMP issues including review and oversight of complex deviations, CAPA and change controls.
  • Provide overall direction for the QA functions within the asset.  Develop team goals, monitor progress and ensure continuous improvement. 
  • Conduct regularly scheduled 1 on 1s with individuals and staff meetings with the teams to review objectives, provide support and feedback and to help resolve issues.    
  • Contribute to the establishment of quality processes that align with Lonza Corporate requirements and standards and current regulatory requirements, meeting US FDA and European requirements, and others as needed.

Key requirements:

  • Bachelor or Master’s Degree. Preferred area of study in Microbiology, Biochemistry, Chemistry or Related Science Fields.
  • Extensive experience within a regulated cGMP industry.
  • Substantial experience with team management.
  • Extensive experience working in a QA role.
  • Project management experience to drive projects to on-time completion.
  • Strong communication and interpersonal skills to grow and mentor an effective team.

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: R33391
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