Senior QA Lead — Biologics ADC Campus

AstraZeneca GmbH; Singapore; On-site; SGD 120,000 - 190,000; Full time

Benefits offered by this job

Office-based with flexible arrangement

Job summary

AstraZeneca invites applications for a Senior Specialist Quality Assurance at the Singapore ADC site, the first biologics campus in Singapore. The role provides end-to-end QA oversight across multiple facilities, spanning raw materials, biologics, small-molecule intermediates, conjugation, sterile filling and packaging.

You will ensure cGMP compliance, data integrity, and robust CAPA processes, collaborating with manufacturing, QC, validation and regulatory teams to enable timely batch release

Qualifications

• Bachelor's or Master’s degree in a science/technical field.
• Significant QA experience in the pharmaceutical/biopharmaceutical 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.

Responsibilities

• Lead QA oversight across multiple facilities, ensuring cGMP compliance and data integrity.
• Provide daily on-the-floor QA presence in manufacturing suites and labs.
• Review investigations, establish root causes, and track CAPAs.
• Approve qualification/validation results and changes within the change framework.
• Support regulatory readiness, audits, and health authority interactions.
• Coordinate supplier quality and ensure materials meet specifications.
• Develop quality metrics and analytics using digital tools to drive improvements.
• Drive continuous improvement and risk management across operations.
• Lead training and coaching of junior QA staff.

Skills

Analytical & problem-solving

Communication skills

Decision making under pressure

Collaboration

Education

Bachelor's or Master’s degree in Science/Technical field

Tools

GxP systems

Quality management software

Job description

AstraZeneca invites applications for a Senior Specialist Quality Assurance at the Singapore ADC site, the first biologics campus in Singapore. The role provides end-to-end QA oversight across multiple facilities, spanning raw materials, biologics, small-molecule intermediates, conjugation, sterile filling and packaging.

You will ensure cGMP compliance, data integrity, and robust CAPA processes, collaborating with manufacturing, QC, validation and regulatory teams to enable timely batch release