Senior Quality Systems Lead - GMP & Compliance

WuXi XDC; Singapore; On-site; SGD 140,000 - 210,000; Full time

Job summary

WuXi XDC is seeking a Senior Quality Specialist to lead and maintain the site's Quality Management System (QMS) ensuring GMP compliance and regulatory alignment. The role partners with cross-functional teams to protect product quality, patient safety, data integrity, and inspection readiness across the product lifecycle.

The successful candidate will complete a 6-month assignment at the Wuxi, China site before returning to Singapore to support XDC Singapore operations, bringing valuable

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related field.
• 10+ years of experience in production and/or quality management, with at least 7 years in QA/quality systems/compliance.
• Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
• Experience setting up quality systems for new sites; biopharma QA experience preferred.
• Proficient in English (listening, speaking, reading, writing) and MS Office skills.

Responsibilities

• Manage and maintain assigned quality system activities, ensuring GMP compliance and regulatory alignment.
• Lead quality system activities including deviation management, CAPA, change control, document control, and risk management.
• Monitor quality system performance through metrics, trend analysis, and management reporting.
• Identify systemic issues and drive improvements in QMS effectiveness.
• Support internal and external audits, regulatory inspections, and customer assessments.
• Facilitate risk assessments using methodologies like FMEA where applicable.
• Ensure quality risks are documented, evaluated, mitigated and escalated.
• Lead or facilitate complex deviation investigations and cross-functional problem solving.
• Influence stakeholders to ensure sound quality decisions with independence.
• Identify opportunities to streamline quality processes while maintaining controls.
• Use quality data and trend analysis to drive process improvements.
• Promote a culture of quality ownership, data integrity, and proactive risk management.
• Facilitate regular management review meetings per internal policies.
• Perform other tasks assigned by leadership.

Skills

Quality system knowledge

Cross-functional collaboration

Analytical thinking

Communication skills

English proficiency

Education

Bachelor's degree or higher in Biologics/Pharmacy/Pharmaceutical Engineering/Bioengineering

Tools

Microsoft Word

Excel

PowerPoint

Job description

WuXi XDC is seeking a Senior Quality Specialist to lead and maintain the site's Quality Management System (QMS) ensuring GMP compliance and regulatory alignment. The role partners with cross-functional teams to protect product quality, patient safety, data integrity, and inspection readiness across the product lifecycle.

The successful candidate will complete a 6-month assignment at the Wuxi, China site before returning to Singapore to support XDC Singapore operations, bringing valuable