Senior Quality Systems Lead - GMP & Compliance Expert

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a Senior Quality Specialist to drive the implementation, maintenance and continuous improvement of the site’s QMS, ensuring GMP compliance, regulatory alignment and product quality across the lifecycle.

The role acts as a subject matter expert, collaborating with cross-functional teams to uphold data integrity, patient safety and inspection readiness, while leading complex investigations and risk-based decision making.

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 and effective cross-functional collaboration.

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.

Skills

Quality management

Cross-functional collaboration

Quality risk management

Attention to detail

Effective communication

MS Office proficiency

Education

Bachelor's degree in Biologics/Pharmaceutical field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a Senior Quality Specialist to drive the implementation, maintenance and continuous improvement of the site’s QMS, ensuring GMP compliance, regulatory alignment and product quality across the lifecycle.

The role acts as a subject matter expert, collaborating with cross-functional teams to uphold data integrity, patient safety and inspection readiness, while leading complex investigations and risk-based decision making.