Associate Director QA - Growth Project

Lead, develop and grow a team of QA Experts. Create and lead the overall Quality strategy. Partner with Senior Project Directors and Senior Project Leadership Team to ensure alignment of Manufacturing and support functions in executing strategy. Act as Lead SME for significant quality / GMP issues. Develop, direct and maintain the local Quality System. Contribute to the development and maintenance of global quality systems in line with Lonza Corporate requirements & standards as well as current regulatory requirements meeting Swissmedic, US FDA and European requirements. Perform independent review and approval of project documents. Take part in investigations, troubleshooting, audits and inspections. Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility. Implement a learning culture and vertical/horizontal knowledge management.

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.

• You have current or previous direct-line leadership experience

• You have the agility, assertiveness and communication skills needed to excel in this highly dynamic project phase

• Eligible to work as as deputy for Qualified Person/FvP in Switzerland or EU as well as extensive work experience in a senior QA role in the GMP controlled pharmaceutical manufacturing environment (e.g. QA Operations), preferably experience in aseptic fill&finish; processes

• Excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation

• Experience in managing customer audits and inspections such as Swissmedic, USFDA, EMA, MHRA Audits

• University degree in Life Science (Pharmacy, Biology or similar field)

• Fluent English and at least basic knowledge of German (plus the willingness to improve your German skills fast in case it is not fluent yet)