Quality R&D Operations API Director

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; its 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.

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.

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.

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.

How to apply
If this role speaks to you we would love to hear from you. Please submit your CV and a short note describing why this role fits your experience and ambitions. Apply today and help us get ahead of disease together.

Skills

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 were 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.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities contact . Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.