Quality R&D Operations API Director

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 150,000 - 190,000; Full time

Job summary

GlaxoSmithKline Pte Ltd in Singapore seeks a senior quality oversight leader for API development in R&D. You will partner with R&D scientists, manufacturing partners, regulatory colleagues and suppliers to ensure patient safety and compliance while driving cross-functional quality improvements.

You will lead inspection readiness, manage regulatory interactions, and drive QMS processes across change control, deviations, CAPA and investigations.

Qualifications

• We are seeking professionals with GMP knowledge and regulatory experience in regulated environments.
• Experience with investigations, CAPA, change control and internal audits is required.
• Proven people leadership, coaching and capability building.
• Willingness to work on-site regularly in Singapore.

Responsibilities

• Lead quality oversight for API development activities in R&D, ensuring GMP compliance.
• Collaborate with R&D, supply and regulatory teams to enable milestones and timely release of materials.
• Own inspection readiness and regulatory interactions, including responses and actions.
• Drive QMS processes across change control, deviations, CAPA, risk assessments and investigations.
• Provide oversight of external suppliers including qualification and audit support.
• Lead, coach and develop a multidisciplinary team in a matrix organisation.

Skills

Quality oversight

GMP

CAPA

Change control

Regulatory compliance

Leadership

Data integrity

Technical writing

Problem solving

Risk management

Education

Life Sciences degree

MSc/PhD preferred

GMP/regulatory knowledge

Job description

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

You will lead quality oversight for Active Pharmaceutical Ingredient (API) activities across R&D operations in Singapore. You will work closely with R&D scientists, manufacturing partners, regulatory colleagues and suppliers. Your team values clear thinking, practical problem solving, and a strong focus on patient safety. This role offers cross-functional leadership, visible impact, and growth as you help unite science, technology and talent to get ahead of disease together.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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 Good Manufacturing Practices (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).

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Advanced degree (MSc, PhD) in a relevant scientific or engineering field.
• Experience with clinical supply chain and GMP for clinical manufacturing.
• Track record handling regulatory inspections and writing regulatory responses.
• Experience overseeing supplier governance and working with other nodes in the supply chain.
• Strong data literacy and experience using metrics to drive decisions and improvement.
• Demonstrated ability to lead in matrix organisations and influence senior stakeholders.

What we value
We look for people who are curious, clear in their thinking and who put patient safety first. We value leaders who coach and develop others, who use data to make decisions, and who act with integrity and transparency. We welcome applicants from all backgrounds and are committed to inclusion in our hiring.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.