Senior Quality Assurance Specialist – ADC Campus

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore and needs a senior QA professional to shape quality systems from day one. You will oversee quality across raw materials, biologics, small‑molecule intermediates, conjugation, sterile filling, lyophilisation, packaging and warehousing.

Key responsibilities

• Provide daily QA oversight on the shop floor, ensuring compliance with cGMP, approved procedures and the site pharmaceutical quality system.
• Lead deviation investigations, root‑cause analysis, CAPA implementation and verification of effectiveness.
• Review and approve validation, qualification, change‑control, product releases and periodic quality reports.
• Support supplier quality, regulatory readiness, audit participation and health‑authority interactions.
• Analyse quality data using digital tools, generate metrics, and drive continuous‑improvement initiatives.

Required profile

• Bachelor’s or Master’s degree in Biotechnology, Pharmaceutical Sciences, Engineering, Biology or Chemistry.
• Significant experience in a large‑scale QA function within highly regulated pharmaceutical or biopharmaceutical manufacturing.
• Strong understanding of cGMP, pharmaceutical quality systems and risk‑based decision making.

Required skills

• cGMP compliance and deviation management.
• CAPA development and tracking.
• Qualification, validation and change‑control processes.
• Regulatory requirements interpretation (GxP, FDA, EMA).
• Digital pharmaceutical systems, data visualisation and analytics platforms.
• AI‑enabled transformation initiatives in a GxP environment.
• Lean, Six Sigma or other process‑improvement methodologies.