Senior QA Expert, Manufacturing

Provide QA oversight for shopfloor manufacturing activities within an exciting growth project, ensuring compliance with GMP requirements and operational readiness. Review and approve SOPs, work instructions, and other GMP documentation to support successful start-up and sustainable manufacturing operations. Partner with Manufacturing teams to drive aseptic process readiness, including preparation, training support, and execution readiness for APS and future media fill activities. Lead and coordinate quality events by reviewing and approving deviations, CAPAs, investigations, and related quality records, ensuring timely and effective resolution. Act as the Quality representative during project discussions, audits, and inspections, clearly communicating the quality oversight strategy and supporting inspection readiness.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Proven experience in the pharmaceutical industry within a GMP-regulated environment, with expertise in sterile and/or drug product manufacturing is a must

• Experience in quality oversight, management of deviations, CAPAs, and investigations.

• Fluent German and fluent English communication skills are essential, enabling effective collaboration with shopfloor operators, cross-functional teams, customers, and regulatory authorities.

• Willingness to spend significant time on the manufacturing shopfloor, including working in full aseptic gowning, and a hands-on approach to supporting operations and driving quality excellence is a must

• Bachelor's, Master's, or PhD degree in Life Sciences, Pharmacy, Chemistry, Biology, Biotechnology, or a related field, combined with a pragmatic, solution-oriented mindset, strong stakeholder management skills, and the agility to thrive in a dynamic greenfield project environment.

• Experience supporting regulatory and customer audits and inspections is an advantage.