Senior QA Specialist, QA Operations

Take responsibility for specific QA operations tasks during the transition from current clinical production to commercial production Assess and manage tasks that are impacting Quality operation during GMP manufacturing Plan for future activities and coordinate with other departments (e.g. QC, Engineering, Manufacturing) to complete the planned activities Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a GMP manufacturing facility Review GMP records to ensure compliance with cGMP per written procedures Make real-time decisions on process events on the floor, based on knowledge of defined SOPs & policies Participate in walkthroughs and audit/inspections

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.

• Academic degree in Life Sciences or a related field

• Significant experience in the pharmaceutical Quality area

• Work experience in a role in Quality Assurance, Production or Engineering, in pharmaceutical industries and cGMP regulated environment

• QA experience in tech transfer is preferred

• Excellent knowledge of computer systems (e.g. TW, SAP, etc.) and quality tools such as risk based approaches (e.g. FMEA)

• Fluent English (written&verbal;) is required.