QA Senior Specialist, Quality System

About the role

The Senior Quality Specialist provides senior-level quality and compliance expertise in implementing, maintaining and continuously improving the site's Quality Management System (QMS) in line with GMP, regulatory expectations and company quality standards. The role acts as a subject matter expert on assigned quality systems, supports risk-based quality decisions and works with cross-functional stakeholders to protect product quality, patient safety, data integrity and inspection readiness. The successful candidate completes a 6-month assignment at the Wuxi China site before returning to Singapore.

Key responsibilities

• Manage and maintain assigned quality system activities in line with GMP, regulatory requirements and internal procedures
• Lead quality system activities such as deviation management, CAPA, change control, document control, quality risk management, complaints, recalls and audits
• Monitor QMS performance through metrics, trend analysis, periodic reviews and management reporting
• Drive improvements, support internal and external audits and inspections, and lead complex deviation investigations
• Facilitate risk assessments (e.g. FMEA) and ensure risks are documented, evaluated, mitigated and escalated
• Promote a culture of quality ownership, data integrity and continuous improvement, and run management review meetings

Required profile

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering or a related field
• At least 10 years in production and/or quality management, with a minimum of 7 years in production QA, quality system QA or compliance QA
• Familiarity with FDA, EMEA, HSA and PIC/S GMP; experience setting up quality systems for new sites and with biopharma commercial quality systems preferred
• Proficiency in English and strong learning ability

Required skills

• Microsoft Word, Excel, PowerPoint
• Cross-functional communication and collaboration