QA Senior Specialist, Quality System

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

• To provide senior-level quality and compliance expertise in the implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS), ensuring compliance with applicable Good Manufacturing Practice (GMP) requirements, regulatory expectations and company quality standards.
• The Senior Quality Specialist serves as a subject matter expert in assigned quality systems, drives effective risk-based quality decisions, and partners with cross-functional stakeholders to maintain product quality, patient safety, data integrity, and inspection readiness across the pharmaceutical product lifecycle.

As part of this role, successful candidate will complete a 6-month assignment at Wuxi China site, gaining valuable experience prior to returning to Singapore to support XDC Singapore operations.

Responsibilities

• Manage and maintain assigned quality system activities, ensuring compliance with the latest GMP regulations, regulatory requirements and internal procedures.
• Lead and facilitate quality system activities, including deviation management, CAPA, change control, document control, and quality risk management, Complaint Management, Product Recall as assigned.
• Monitor quality system performance through appropriate metrics, trend analysis, periodic reviews, and management reporting.
• Identify systemic issues and drive sustainable improvements in QMS effectiveness
• Support internal audits, external audits, regulatory inspections and customer assessments.
• Facilitate risk assessments using appropriate methodologies, such as failure mode and effect analysis (FMEA), where applicable
• Ensure quality risks are appropriately documented, evaluated, mitigated and escalated
• Lead or facilitate complex deviation investigations and cross-functional problem solving activities.
• Influence stakeholders to make sound quality decisions while maintaining appropriate independence and objectivity.
• Identify opportunities to streamline quality processes while maintaining compliance and effective controls.
• Use quality data, metrics, and trend analysis to identify improvement opportunities and assess the effectiveness of quality processes.
• Promote a culture of quality ownership, data integrity, proactive risk management, and continuous improvement.
• Facilitate regular management review meetings in accordance with internal policies.
• Perform other tasks assigned by leadership.

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 10 years of working experience 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 requirements.
• Experience in setting up quality systems for new sites is preferred.
• Experience with biopharma commercial quality systems is preferred.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, etc.
• Strong learning ability.
• Effective at cross-functional communication and collaboration.