Lead Compliance Auditor - QA & GxP (On-Site)

Randstad – Lonza; Singapore; On-site; SGD 100,000 - 140,000; Full time

Job summary

Lonza Singapore, a global leader in biopharmaceuticals, seeks a Lead Specialist, Compliance (Audit Management) to support GMP activities at our Tuas site. This fully site-based role requires close collaboration with manufacturing and QA teams to uphold high quality and regulatory standards.

You will develop internal GxP auditing skills, lead inspections, manage deviations, and drive cross-functional improvements within Lonza's global QA framework.

Qualifications

• Bachelor's degree in Quality Assurance within the biopharmaceutical sector is required.
• Proven experience in QA operations in a GMP-regulated biopharma environment.
• Strong understanding of quality management systems and GMP compliance requirements.

Responsibilities

• Develop skills as an internal GxP auditor, as required.
• Provide support in regulatory inspections and customer audits as required.
• Lead audit walk-down preparation and provide feedback as required.
• Lead in audit / inspection response as required.
• Lead in complex deviation investigations as required.
• Own documents of the assigned Quality Process when applicable.
• Develop skills to be Qualified Trainer in area of expertise.
• Subject Matter Expert in one or more area of expertise.

Skills

QA operations

GMP compliance

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Quality Assurance (biopharma)

Tools

Audit management systems

CAPA tracking

Job description

Lonza Singapore, a global leader in biopharmaceuticals, seeks a Lead Specialist, Compliance (Audit Management) to support GMP activities at our Tuas site. This fully site-based role requires close collaboration with manufacturing and QA teams to uphold high quality and regulatory standards.

You will develop internal GxP auditing skills, lead inspections, manage deviations, and drive cross-functional improvements within Lonza's global QA framework.