Head Global Quality Systems and Compliance DPS Growth Project 80-100% (m/f/d)

Switzerland, Basel
Switzerland, Stein

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.

Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position Head Global Quality Systems and Compliance DPS Growth Project 80-100% (m/f/d).

Providing strategic leadership for the entire Drug Product Services (DPS) Quality Management System (QMS) and Compliance Principles in line with the regulations as well as (lean) six sigma principles to ensure that the compliance positioning of DPS is accurate and Customer experience is best in class

Key responsibilities:

  • Design a  local to global  Quality System Strategy for DPS involving relevant stakeholders to define a best in class endpoint.

  • Ensure consistency of the document framework (guidance documents, standards, SOPs), as well as accurate positioning in light of current regulatory expectations and anticipated industry trends

  • Tailor the global system framework to the endpoint of a highly efficient, best in class newly built facility and ensure execution on the ground

  • Leverage Network / Benchmark Learnings and apply to the newly built Facility QA Approach, for e.g among others award best in class practices (Raykoon Steel with Pride)

  • Lead project teams to ensure Lonza Processes used in DPS are fully aligned with DP Q standards and HA regulations.

  • Providing guidance, expertise and coaching, assisting sites and their teams for policies, procedures and specifications

  • Serve as senior Drug Product Quality expert, providing solid, well-informed, actionable Quality support to the Drug Product Services BU 

  • Serve as a Coach / Mentor for Network Key Talents in order to ensure talents development.

Key requirements:

  • Academical degree (Bachelor or higher)  in a Life Sciences, Engineering or Quality Management or related science discipline

  • Substantial working experience in GMP manufacturing and Quality Management Systems of products regulated by FDA CBER or CDER or EMA

  • Substantial experience in a leadership positions

  • Lean Six Sigma Experience (Green/Black Belt Preferred), ability to design data driven Governance Systems

  • Experience in aseptic processing/sterile manufacturing

  • Fluency in English, German is an asset

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.

Reference: R52289
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