Lead / Senior Specialist, QA (External)

About the role

Lonza is hiring a Lead / Senior Specialist, QA (External) for its Tuas site in Singapore. This is a fully site-based role supporting day-to-day Quality Assurance activities in the biopharmaceutical industry, where close, real-time collaboration is needed to manufacture medicines to the highest quality and safety standards.

Key responsibilities

• Support daily QA activities in compliance with approved SOPs, policies and cGxP requirements.
• Review and approve SOPs, protocols, reports and quality records.
• Lead deviation investigations, change controls, CAPA plans and troubleshooting activities.
• Ensure data integrity and drive continuous quality improvement.
• Support and lead regulatory inspections, customer audits and audit responses.
• Perform material release, qualification, defect inspections and review vendor investigation reports.
• Lead projects, manage deliverables and coordinate cross-functional activities.
• Maintain stakeholder relationships and develop training and internal GxP auditing competencies.
• Participate in facility walkdowns and perform other duties as assigned.

Required profile

• Degree or higher from a recognised institution with 3 to 10 years' experience in validation or quality within a biopharmaceutical unit.
• Familiarity with regulatory requirements and local codes and standards such as FDA, EMEA and ICH Q7.
• Good knowledge of the practical and theoretical requirements of a quality management system in a GMP facility.
• Ability to work independently, with a strong focus on safety, quality and timelines.

What we offer

• Competitive compensation programmes recognising high performance.
• Comprehensive medical insurance, with family members at partially subsidised premiums.
• Company transport from designated MRT stations to and from the Tuas site.
• Full employee benefits suite and professional growth through cross-functional projects and global exposure.