Lead Specialist, Quality Control (Stability)

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards What you will get: An agile career and dynamic working culture.

About Lonza

• Lonza 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.

Ready to shape the future of life sciences?

Apply now.

Responsibilities

• Lead and author protocols and reports for stability studies and investigations.
• Support in-house and external product stability programs, including stability pulls, shipment coordination, and stability LIMS setup.
• Collaborate with cross-functional teams to resolve communication, compliance, and documentation issues.
• Provide timely project updates and key data to relevant stakeholders.
• Manage preventive maintenance and requalification of stability chambers and related equipment.
• Troubleshoot equipment and method-related issues, performing data mining, trending, and analysis to identify and resolve problems.
• Manage multiple priorities while ensuring timely and compliant delivery of activities.
• Contribute to Annual Product Reviews and other regulatory documentation.
• Drive operational efficiency and continuous improvement initiatives.
• Participate in internal and external audit activities as required.
• Uphold data integrity principles in accordance with Lonza policies and proactively identify opportunities to strengthen data integrity processes.
• Perform other duties as assigned by the manager.

Requirements

• Degree or higher in Life Sciences/Pharmaceuticals with extensive experience in supervisory/project management roles within QC/QA.
• 5+ years of experience in quality or manufacturing operations in a GMP, FDA, and EU-regulated pharmaceutical environment.
• In-depth knowledge of regulatory requirements, including FDA and EMEA guidelines.
• Strong expertise in validation programs within GMP facilities.
• Demonstrated ability to set clear goals, prioritize tasks, and make balanced decisions to meet deadlines.
• A team player with a focus on safety, quality, and timelines.
• Adaptability to fast-paced environments and capability to lead organizational change.
• Excellent conflict resolution skills.

Benefits

• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Daily company bus from the MRT location near your home to and from the Tuas site.
• Fully paid medical insurance, and option to enrol family members at partially subsidized premiums.