Quality R&D Operations API Director
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.
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
Uniting science, technology and talent to get ahead of disease together.
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Not included in the source posting: about the role, what you'll do, benefits.
Skills
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