Lead Specialist, Quality Control (Stability)

About the role

This is a fully site-based role at Lonza's Tuas site, where close, real-time collaboration is needed to manufacture medicines to the highest quality and safety standards. The position leads stability studies and investigations and supports product stability programs.

Key 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 stakeholders.
• Manage preventive maintenance and requalification of stability chambers and related equipment.
• Troubleshoot equipment and method issues through data mining, trending and analysis.
• Contribute to Annual Product Reviews and other regulatory documentation.
• Drive operational efficiency and continuous improvement, and take part in internal and external audits.
• Uphold data integrity in line with Lonza policies.

Required profile

• Degree or higher in Life Sciences/Pharmaceuticals with extensive supervisory/project management experience in 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.
• Ability to set goals, prioritize tasks and meet deadlines, with adaptability to fast-paced environments and leadership of change.

What we offer

• A daily company bus from the MRT near your home to and from the Tuas site.
• Fully paid medical insurance, with the option to enrol family members at partially subsidized premiums.
• An agile career, inclusive workplace and compensation programs for high performance.