Associate Director / Head of QA Qualification, CAPEX Project 80-100%

Location: Stein AG (Switzerland)

Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five 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.

Are you prepared to lead and have an impact in the life sciences industry? Lonza AG is searching for an outstanding candidate for the position of Associate Director / Head of QA Qualification, CAPEX Project in Switzerland. This is an outstanding chance to lead the quality oversight during the critical Commissioning & Qualification phases of GMP-relevant systems in the scope of a large capital investment project. Join us in our ambitious mission to deliver world-class scientific solutions!

What you’ll get:

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

What you’ll do

• Leadership: Train, supervise, and guide the QA Engineering Team to ensure flawless execution of Capex project and being right first time in compliance.

• Supervise the quality and compliance duties across diverse project phases, from Commissioning and Qualification (C&Q) to the handover to Operations.

• Verify that Direct Impact Systems (such as facilities, equipment, utilities, and computerized systems) are qualified for their intended use by meeting Lonza's standards and regulatory requirements.

• Manage Quality Risks and compliance gaps to minimize the impact of potential quality issues and ensure regulatory compliance.

• Provide leadership and guidance on  C&Q documentation, including DQ, FAT/SAT, IV, OFT, IQ, OQ, and QR.

• Assist with the progression of project stages from planning and C&Q execution to the handover to Operations and Inspection Readiness.

• Work together with the Project Leadership Team to guarantee synchronization of the project implementation strategy and attain quality and compliance objectives.

What we’re looking for:

• University degree in life sciences or engineering, or equivalent experience.

• Proven experience as Project Quality Lead, experience in lifecycle qualification, experience in leading/managing a CAPEX project, or prior MSAT experience is a must.

• Experience in aseptic/sterile manufacturing (EU Annex 1) is a must.

• Experience in commissioning, qualification & validation (EU Annex 15) is a must (practical hands-on experience is a plus)

• Direct line team lead experience is a must

• Proficient in English; Knowledge of German is a bonus.

Join Lonza AG and be part of an environment where your expertise is valued, and your career can flourish. We look forward to welcoming you to our 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.