Senior Specialist, Quality Engineering (QA)

About the role

The Senior Specialist, Quality Engineering provides operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse and Quality Control (QC) operations. The role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines, Data Integrity requirements and company quality standards. It also serves as the Site Data Integrity (DI) Champion, overseeing qualification and validation activities, engineering and computerized system lifecycle management, warehouse and laboratory compliance, risk management, inspection readiness and continuous improvement. The successful candidate completes a 6-month assignment at the Wuxi China site before returning to Singapore.

Key responsibilities

• Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, CSV, Warehouse and QC operations, and give independent quality decisions on product quality, patient safety, data integrity and regulatory compliance.
• Support deviations, investigations, CAPAs, change controls, QRAs, gap assessments, SOPs, protocols, validation documentation and technical reports, and take part in audit and inspection readiness.
• Review and approve qualification and validation activities, protocols, reports and qualification documents, and oversee engineering changes and the lifecycle of GMP infrastructure and systems.
• Oversight warehouse operations (receipt, storage, dispensing, inventory, distribution) and QC operations (laboratory investigations, OOS/OOT events, CAPAs, change controls).
• Serve as Site DI Champion: lead the Data Integrity Governance Program, promote ALCOA+ principles, review DI risk assessments and gap assessments, and drive DI training and compliance monitoring.
• Manage project timelines, quality deliverables, KPIs, budget planning and resource allocation, and work with Engineering, Validation, Manufacturing, Warehouse, QC, Supply Chain, IT and Regulatory Affairs.
• Lead quality escalations, compliance risks and critical quality events, and support site expansion, technology transfer, validation programs and digitalization initiatives.

Required profile

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, Computer Science, Information Systems or a related discipline; advanced degree preferred.
• Minimum 7 years of experience in pharmaceutical, biotechnology, biologics, ADC or CDMO environments.
• Ability to balance business objectives with the highest standards of quality and regulatory compliance.

Required skills

• Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11 and Data Integrity requirements.
• Expertise in validation lifecycle management, Quality Risk Management, compliance gap assessments and GMP quality systems.
• Understanding of engineering systems, utilities, HVAC, process gases, computerized systems, warehouse operations and QC laboratory processes.
• Excellent quality decision-making, stakeholder management, problem-solving and communication skills.