Senior QA Lead - GMP, CAPA & Regulatory Audits (Onsite)

Lonza Group Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Medical insurance

Transport from MRT to Tuas site

Global exposure

Professional growth opportunities

Job summary

Lonza in Singapore is seeking a QA Specialist to support day-to-day QA activities in a fully site‑based role. Working in person enables real-time collaboration and the precision needed to manufacture medicines to the highest quality standards.

You will review SOPs and records, lead deviation investigations and CAPA plans, ensure data integrity, and support regulatory inspections and audits while maintaining strong stakeholder relationships.

Qualifications

• Degree or higher with 3–10 years in Validation/Quality in the Biopharmaceutical industry.
• Familiar with regulatory requirements (FDA, EMEA, ICH Q7).
• Good knowledge and experience with GMP quality systems.

Responsibilities

• Support daily QA activities in compliance with SOPs, policies and cGxP.
• Review and approve SOPs, protocols, reports, and quality records.
• Lead deviation investigations, change controls, CAPA plans, and troubleshooting.
• Ensure data integrity and drive continuous quality improvement.
• Support 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.

Skills

GxP knowledge

Regulatory knowledge

Quality management

Team player

Education

Bachelor's degree in Life Sciences

Job description

Lonza in Singapore is seeking a QA Specialist to support day-to-day QA activities in a fully site‑based role. Working in person enables real-time collaboration and the precision needed to manufacture medicines to the highest quality standards.

You will review SOPs and records, lead deviation investigations and CAPA plans, ensure data integrity, and support regulatory inspections and audits while maintaining strong stakeholder relationships.