Senior QA Operations Lead: cGMP & Compliance

GSK; Singapore; On-site; SGD 78,000 - 123,000; Full time

Job summary

GSK Singapore is seeking a Senior / QA Operations Executive to provide QA oversight and ensure cGMP compliance across Manufacturing and Quality Control operations.

You will manage batch usage decisions, deviations, CAPAs, audits, and release authorizations in line with defined QMS requirements and regulatory standards.

The role requires strong QA expertise, QMS familiarity, effective on-site communication, and the ability to drive continuous improvement within a fast-paced biopharma environment.

Qualifications

• Experience in pharmaceutical/biotech/regulated industries.
• Minimum 2 years for QA Executives; 5 years preferred for Senior QA Executive.
• Strong understanding of GMP and regulatory requirements.
• Proficient with Quality Management Systems (QMS).
• Ability to communicate effectively within the site.
• Risk-based thinking and issue resolution skills.

Responsibilities

• Provide QA oversight to ensure cGMP compliance across Manufacturing and QC operations.
• Manage batch usage decisions, deviation management, audits, and release authorizations.
• Review and approve manufacturing and QC documents including Master Batch Records and QC reports.
• Support site inspections and audits; perform risk assessments and gap analyses.
• Lead CAPA and change controls to prevent recurrence.
• Coach junior staff and act as SME for QA processes.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Job description

GSK Singapore is seeking a Senior / QA Operations Executive to provide QA oversight and ensure cGMP compliance across Manufacturing and Quality Control operations.

You will manage batch usage decisions, deviations, CAPAs, audits, and release authorizations in line with defined QMS requirements and regulatory standards.

The role requires strong QA expertise, QMS familiarity, effective on-site communication, and the ability to drive continuous improvement within a fast-paced biopharma environment.