Senior QA Expert Compliance

Lead and participate in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with cGMP, ISO, and other applicable regulatory requirements. Act as a subject matter expert for compliance-related topics, providing guidance and training to various departments on quality principles, regulatory expectations, and best practices. Manage and investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring timely resolution and effectiveness checks. Review and approve quality-related documentation, including but not limited to standard operating procedures (SOPs). Prepare and present compliance reports and metrics to management, highlighting trends, risks, and proposed mitigation strategies. Represent the company during regulatory inspections and customer audits, responding to inquiries and demonstrating robust compliance practices. Collaborate cross-functionally with Manufacturing, QC, MSAT, Engineering, Supply Chain and other departments to embed quality into all stages of the product lifecycle. Stay abreast of evolving global regulations and industry trends related to quality and compliance, proactively assessing their impact on Lonza's operations

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.

• MSc (minimum BSc, PhD preferred) in a scientific field with extensive experience in a QA function within the GMP controlled, pharmaceutical manufacturing environment is a must

• Strong QMS background with proven experience in deviations, CAPA, change control, and document management within GMP environments

• Hands-on experience with document management and quality systems (e.g., TrackWise, MasterControl, DMS, Cornerstone); Experience with Veeva is highly beneficial

• Experience in sterile manufacturing, pharma production, clinical testing, or similar with focus on compliance and training oversight

• Analytical, decisive, and resilient professional who communicates complex topics clearly, works independently, and thrives in fast-paced, changing environments