Senior Specialist Quality Assurance

Job Title: Senior Specialist Quality Assurance

Career Level: D

About Singapore ADC:

About Singapore ADC Site:

Be part of history in the making. AstraZeneca is building its first biologics manufacturing campus in Singapore - a groundbreaking USD 1.5 billion investment that will serve as a global hub for innovation and excellence.

This innovative facility will deliver end-to-end Antibody-Drug Conjugate (ADC) capabilities with different manufacturing units/buildings in one campus:

• Small molecule- chemical API production
• Large molecule- monoclonal antibody manufacturing
• Conjugation
• Fill-and-finish operations, including sterile filling and lyophilization
• Final secondary packaging

The campus will be equipped with innovative digital and automation infrastructure, enabling autonomous manufacturing powered by artificial intelligence. In addition, it will be designed for carbon neutrality, embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologic's manufacturing.

Introduction to role: Are you ready to help build world-class Quality Assurance capability from the ground up at a first-of-its-kind biologics campus in Singapore? This is a rare opportunity to shape the standards, systems and culture that will bring life-changing medicines to patients faster and more reliably.

As Senior Specialist Quality Assurance, you will provide end-to-end QA oversight across one or more facilities within our new campus, spanning raw materials, biologics and small-molecule intermediates, conjugation, sterile filling and lyophilization, packaging, QC and warehousing. The site brings advanced digital and automation technologies together with a sustainability-first design, enabling autonomous, AI-powered manufacturing with a clear path to carbon neutrality. Can you see yourself setting robust, right-first-time practices that scale with our growing ADC portfolio and inspire colleagues to set the standard?

We are recruiting several roles across different manufacturing nodes, creating a network of QA leaders who will set the foundation for an integrated, data-driven quality system from day one.

Accountabilities:

• QA Leadership and Oversight: Guide execution of core quality processes across internal manufacturing and control, including local supplier quality, ensuring timely, accurate documentation and data integrity to enable confident batch release and flow of materials.
• On-the-Floor Presence: Provide direct, daily QA oversight in manufacturing suites, labs and support areas to ensure activities align with cGMP, approved procedures and the site pharmaceutical quality system.
• Deviation and CAPA Excellence: Review & approve investigations, establish true root causes, define and track effective CAPAs, and verify sustained effectiveness to reduce recurrence and improve process capability.
• Validation, Change and Release: Review and approve qualification and validation results, changes within the change management framework, QA release, product quality reviews, periodic reports and related documentation.
• Regulatory and Inspection Readiness: Advise on GxP expectations, coordinate regulatory documents and referrals, and actively participate in audits, inspections and health authority interactions to maintain a state of control.
• Supplier and External Quality: Support local supplier management to ensure materials and services meet specifications and compliance requirements, highlighting and resolving issues with urgency.
• Digital Quality and Analytics: Conduct data analysis and develop clear reports and insights on quality metrics and benchmarks using digital tools; translate trends into actions that improve compliance, flow and reliability.
• Continuous Improvement and Risk Management: Benchmark internal and external practices, run risk assessments, and identify innovative, efficient approaches to strengthen the quality system and streamline operations.
• Customer Complaint Management: Lead and approve complaint investigations and ensure timely closure with robust corrective and preventive actions.
• Training and Coaching: Plan and deliver quality training; coach early-career team members on processes, systems, digital tools and compliance so the team can scale confidently.

Essential Skills/Experience:

• Bachelor's or Master´s degree in a science/technical field such as Biotechnology, Pharmaceutical Sciences, Engineering, Biology or Chemistry.
• Significant experience working within a sizeable QA function in the pharmaceutical or biopharmaceutical highly regulated manufacturing environments.
• Strong understanding of cGMP requirements and Pharmaceutical Quality Systems.
• Experience providing quality oversight within manufacturing/ QC, validation, and related operations.
• Experience supporting investigations, deviation management, CAPAs, and risk assessments.
• Ability to make sound, risk-based decisions in a fast-paced operational environment.
• Strong analytical and problem-solving skills with the ability to manage complex quality issues.
• Excellent communication, collaboration, and customer management skills.
• Ability to interpret regulatory requirements and apply them within operational settings.
• Strong organisational skills with the ability to manage multiple priorities and changing business needs with desire to support manufacturing operations.

Desirable Skills/Experience:

• Experience within several areas across biological, synthetic active pharmaceutical ingredient, sterile/aseptic, biopharmaceutical manufacturing environments, QC, packaging or warehouse.
• Experience supporting new product introductions, technology or analytical transfers or significant validation programmes.
• Experience and knowledge using digital pharmaceutical systems, data visualisation platforms, or analytics solutions to improve quality outcomes.
• Experience supporting digital, automation or AI-enabled transformation initiatives within a GxP environment.
• Familiarity with process improvement methodologies such as lean,six sigma, or operational excellence frameworks.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca: Be part of a company launching a next-generation ADC campus in Singapore that unites end-to-end manufacturing with leading digital and automation capabilities, all underpinned by a bold sustainability agenda. You will collaborate with diverse experts who move at pace to solve complex challenges, see your quality decisions translate quickly to patient impact, and grow through real responsibility, continuous learning and global exposure. We value kindness alongside ambition, empower you to take ownership, and give you the platform to influence standards that will shape how we make medicines across our network.

Call to Action: Own the quality backbone of a fully integrated ADC campus and amplify your impact on patients-submit your application today to lead from the start.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.