Senior Specialist - Quality Control

AstraZeneca; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

AstraZeneca Singapore is seeking a Senior Specialist in Quality Control to lead technology-enabled QC activities and drive method transfers across the manufacturing network. You will mentor colleagues, ensure data integrity, and support audit readiness to deliver safe medicines.

You will evaluate new QC instrumentation, guide digital tooling adoption (LIMS, Empower, SAP), and collaborate with QA and Regulatory teams to sustain compliant, efficient operations in a fast-paced biologics campus.

Qualifications

• Experience in regulated laboratory environments performing microbiological or analytical QC testing.
• Experience learning and implementing newer digital tools and technologies related to QC reporting, documentation, and analysis
• Experience driving compliance management and relevant GxP

Responsibilities

• Technology Introduction: evaluate and embed new QC instrumentation, methods, and systems to stay current and compliant.
• Method Transfer Leadership: lead analytical technology transfer of QC methodology into Operations and scalable transfer protocols.
• Analytical Excellence and Troubleshooting: resolve non-routine testing and instrumentation issues using digital tools.
• Training and Coaching: build capability across QC teams on equipment operation, digital QC systems, and best-practice compliance.
• Multi-Functional Planning: collaborate across Manufacturing, QA, Regulatory, Development and external partners to support reliable supply.
• Inspection Readiness and Support: prepare documentation and SMEs for regulatory inspections with data-driven rationale.

Skills

QC testing

Data integrity

Digital tools adoption

GxP compliance

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MODA

1Lab

Empower

SAP

Job description

Job Title: Senior Specialist - Quality Control

Career Level: D

About Singapore ADC:

About Singapo0re 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 elevate Quality Control by embedding new technologies and shaping methods that speed safe, reliable medicines to patients? In this senior role, you will connect scientific rigor with real-world delivery, helping our manufacturing network release products right-first-time and at pace. Your expertise will resolve complex analytical and microbiological issues, strengthen data integrity, and improve for inspection readiness.

You will be the go-to technical expert for QC, guiding method transfers, advancing digital tools, and mentoring colleagues so the lab runs smoothly every day. Can you see yourself turning innovation into standard practice while ensuring compliance never slips? If so, this is your opportunity to drive measurable improvements in cycle time, cost of non-quality, and product quality that patients depend on.

Accountabilities:

• Technology Introduction: Evaluate, introduce, and embed new QC instrumentation, methods, and systems to keep the laboratory current, competitive, and compliant.
• Industry Scouting and Proposal Development: Monitor emerging standards and innovations; develop clear proposals and business-cases for implementation that improve speed, robustness, and data integrity.
• Method Transfer Leadership: Lead analytical technology transfer of QC methodology into and out of Operations, designing transfer protocols and strategies that are audit-ready and scalable.
• Analytical Excellence and Troubleshooting: Provide expert guidance to resolve non-routine testing, instrumentation, and methodology issues, leve-raging digital tools to prevent recurrence.
• Training and Coaching: Build capability across the QC team through targeted training, coaching, and knowledge sharing on equipment operation, digital QC systems, and best-practice compliance.
• Multi-Functional Planning: Collaborate with Manufacturing, Quality Assurance, Regulatory, Development, and external partners to plan and implement QC operations that support reliable supply.
• Inspection Readiness and Support: Prepare documentation, evidence, and SMEs for regulatory inspections; respond to queries with clarity and data-driven rationale.
• Mentorship and Compliance Stewardship: Guide early-career team members on QC processes, GxP expectations, and data integrity principles, reinforcing a culture of continuous improvement.

Essential Skills/Experience:

• Bachelor 's degree or equivalent in a scientific dis-cipline
• Prior experience in a regulated laboratory environment conducting microbiological or analytical QC testing
• Experience learning and implementing newer digital tools and technologies related to QC reporting, documentation, and analysis
• Experience driving compliance management and relevant GxP

Desirable Skills/Experience:

• Experience in green field or brown field projects to setup Quality Control laboratories
• Experience in establishing QC operation system (procedures and processes) for product introduction and supply
• Experience in establishing site environmental monitoring program for clean room and clean utilities
• Proficient in test methods transfer or validation for incoming raw materials, intermediates, drug substance (mAb) and drug product (Fill and Finish)
• Experience in supporting in QC digital system (LIMS, MODA, 1Lab, Empower and/or SAP) site implementation

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:

Here, your QC expertise powers a mission that turns breakthrough science into reliable supply for patients worldwide. You will work should