API Quality Director, R&D Operations & Compliance

GSK; Singapore; On-site; SGD 180,000 - 280,000; Full time

Job summary

GSK Singapore seeks a seasoned professional to lead quality oversight for API development in R&D operations. You will collaborate with R&D scientists, manufacturing partners, regulatory colleagues and suppliers to ensure patient safety and regulatory compliance.

You will drive QMS initiatives, CAPA, change control and risk assessments, while coaching a multidisciplinary team to build capability and deliver high-quality clinical materials on schedule.

Qualifications

• Bachelor\'s degree in Life Sciences, Pharmacy, Chemical/Biochemical Engineering or related discipline.
• Minimum 8 years of experience in pharmaceutical quality, API/drug substance or biologics development.
• Practical knowledge of GMP and regulatory expectations in regulated environments (e.g. HSA, FDA, EMEA).
• Experience with quality systems: investigations, CAPA, change control and internal audits.
• Proven people leadership experience, including coaching and capability building.
• Willingness to work on-site regularly in Singapore (this role is on-site).

Responsibilities

• Lead quality oversight for API development activities in R&D operations, ensuring compliance with current Good Manufacturing Practices and regulatory expectations.
• Partner with R&D, supply and regulatory teams to enable development milestones and timely release of clinical materials.
• Own inspection readiness and regulatory interactions, including preparing technical responses and managing inspection actions.
• Drive quality systems, QMS compliance and processes for R&D workstreams: change control, deviations, CAPA, risk assessments and investigations.
• Provide oversight of external suppliers including supplier qualification and audit support
• working with other nodes in the supply chain to support business needs and implement improvements
• Lead, coach and develop a multidisciplinary team; set clear objectives and build capability through practical coaching.

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

Education

Bachelor\'s degree in Life Sciences/Pharmacy/Engineering

Advanced degree (MSc, PhD) in relevant field

Job description

GSK Singapore seeks a seasoned professional to lead quality oversight for API development in R&D operations. You will collaborate with R&D scientists, manufacturing partners, regulatory colleagues and suppliers to ensure patient safety and regulatory compliance.

You will drive QMS initiatives, CAPA, change control and risk assessments, while coaching a multidisciplinary team to build capability and deliver high-quality clinical materials on schedule.