Lead Specialist, Quality Control (Stability)

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Daily MRT bus to Tuas site

Fully paid medical insurance

Family medical coverage option

Competitive compensation

Job summary

Lonza Biologics Tuas Pte Ltd is seeking a senior professional to lead stability studies and related quality/manufacturing activities in a fully site-based role in Singapore. You will author protocols, manage stability programs, and collaborate across functions to ensure data integrity and regulatory compliance.

The role requires extensive experience in GMP environments, strong project management, and a proactive approach to continuous improvement and audits.

Qualifications

• Degree or higher in Life Sciences/Pharmaceuticals with supervisory/project management experience.
• 5+ years in quality or manufacturing ops in GMP/FDA/EMEA environments.
• Strong knowledge of FDA/EMEA guidelines.
• Experience with validation programs in GMP facilities.

Responsibilities

• Lead and author protocols and reports for stability studies and investigations.
• Support in-house and external stability programs including stability pulls, shipment coordination and 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, perform data mining and trend analysis.

Skills

Project management

Quality systems

Stakeholder coordination

Regulatory compliance

Data integrity

Education

Degree in Life Sciences / Pharmaceuticals

Tools

Stability LIMS

Job description

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.
• 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.

What you will do:

• 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.

What we are looking for:

• 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.

About 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.