Lead Specialist, Quality Control

Lonza; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Daily company bus from MRT to Tuas

Fully paid medical insurance

Dependent coverage option

Job summary

Lonza Lead Specialist, Quality Control (Stability) is a site‑based role in Singapore. You will lead protocols for stability studies, coordinate stability programs, and ensure compliance and data integrity across audits and regulatory requirements.

The role requires a strong background in GMP environments and collaboration across cross‑functional teams. You will be responsible for stabil ity chamber maintenance, data analysis, and driving continuous improvement while upholding Lonza’s standards.

Qualifications

• Degree or higher in Life Sciences/Pharmaceuticals.
• 5+ years in quality or manufacturing operations in GMP/FDA/EMEA regulated pharma env.
• Knowledge of regulatory requirements (FDA/EMEA).
• Strong GMP validation experience.

Responsibilities

• Lead and author protocols and reports for stability studies and investigations.
• Support stability programs including pulls, shipments, and LIMS setup.
• Collaborate with cross-functional teams to resolve communication, compliance and documentation issues.
• Provide timely project updates to stakeholders.
• Manage preventive maintenance and requalification of stability chambers and equipment.
• Troubleshoot equipment/method issues with data mining and trend analysis.
• Handle multiple priorities ensuring timely, compliant delivery.
• Contribute to Annual Product Reviews and regulatory documents.
• Drive operational efficiency and continuous improvement initiatives.
• Participate in internal/external audits as required.

Skills

Quality control

Project management

Data integrity

Regulatory awareness

Education

Life Sciences/Pharmaceuticals degree

Tools

Stability LIMS

GMP validation

Validation programs

Job description

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.
• 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.

Reference: R80480

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast‑moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.