Senior Stability & Quality Control Lead

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

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.