Senior QA Lead, Biopharma | Compliance & CAPA Expert

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Medical insurance

Transport from MRT stations to Tuas

Global exposure

Benefits package

Job summary

Lonza Singapore is seeking a QA Specialist for a fully site-based role. You will support day-to-day QA activities, review documents, lead deviation investigations, and drive CAPA and regulatory responses to ensure data integrity and high-quality medicines.

The position emphasizes close in-person collaboration, cGxP compliance, and ongoing training across cross-functional teams, with growth opportunities within a global life sciences leader.

Qualifications

• Degree or higher from a recognized institution with 3 to 10 years' experience in Validation / Quality unit in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (FDA, EMEA, ICHQ7).
• Good knowledge and experience of quality management systems in a GMP facility.

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 strong stakeholder relationships and develop training and internal GxP auditing competencies.

Education

Degree or higher

Job description

Lonza Singapore is seeking a QA Specialist for a fully site-based role. You will support day-to-day QA activities, review documents, lead deviation investigations, and drive CAPA and regulatory responses to ensure data integrity and high-quality medicines.

The position emphasizes close in-person collaboration, cGxP compliance, and ongoing training across cross-functional teams, with growth opportunities within a global life sciences leader.