Senior Batch Release & QA Lead

Sanofi; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Sanofi in Singapore is seeking a Batch Release Lead to provide QA oversight for the disposition, release and related quality activities of drug substances. You will ensure compliant dispositioning in line with GMP and regulatory standards across manufacturing, quality and regulatory functions.

The role also supports quality investigations, audits and continuous improvement to strengthen site quality systems and operational effectiveness, enabling timely batch disposition decisions.

Qualifications

• 5+ years of QA experience in the pharmaceutical industry.
• Strong knowledge of GMP requirements and QA principles.
• Experience supporting investigations, change controls and CAPA processes.
• Familiarity with regulatory requirements and quality systems.

Responsibilities

• Perform final drug substance disposition for batch release.
• Review batch-related quality information before disposition.
• Investigate deviations impacting batch release and ensure proper CAPA.
• Lead QA review of site deviations and investigations.
• Coordinate complaint investigations and reports as needed.
• Review and approve site change controls and PQRs.
• Support audits, inspections and readiness activities.

Skills

Batch disposition

Deviation management

GMP knowledge

QA investigations

Root cause analysis

Cross-functional collaboration

Job description

Sanofi in Singapore is seeking a Batch Release Lead to provide QA oversight for the disposition, release and related quality activities of drug substances. You will ensure compliant dispositioning in line with GMP and regulatory standards across manufacturing, quality and regulatory functions.

The role also supports quality investigations, audits and continuous improvement to strengthen site quality systems and operational effectiveness, enabling timely batch disposition decisions.