Senior Quality Specialist

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 110,000 - 150,000; Full time

Job summary

WuXi XDC Singapore Private Limited seeks a Senior Specialist I/II to own and advance the Quality Risk Management program at the site, serving as the QRM SME and system owner. You will drive risk governance, provide dashboards, and support audits and inspections to ensure compliance with ICH Q9 and GMP requirements.

You will lead risk assessments across GMP operations, enable data-driven decisions, and coach site personnel on risk-based quality practices to foster a robust quality culture.

Qualifications

• 5-8 years of GMP experience within pharmaceutical, biotechnology, biologics, ADC, or CDMO environments.
• Strong knowledge of ICH Q9, FDA cGMP, EU GMP, PIC/S GMP, Quality Risk Management tools, and GMP quality systems.
• Experience in Quality Systems, Quality Assurance, Compliance, Validation, or Risk Management.

Responsibilities

• Own and maintain the site Quality Risk Management (QRM) Program, procedures, templates, and governance processes.
• Serve as System Owner for the Quality Risk Management System and Site Risk Register.
• Facilitate and support cross-functional risk assessments for GMP operations, change controls, deviations, CAPAs, validation, facilities, utilities, computerized systems, warehouse, and QC activities.
• Maintain and monitor the Site Risk Register, including risk escalation, mitigation tracking, and periodic review.
• Provide site-level risk trending, dashboards, metrics, and management review reports to Quality and Site Leadership.
• Ensure risk assessments comply with ICH Q9 principles and support effective risk-based decision making.
• Lead QRM training, coaching, and awareness programs across the site.
• Support regulatory inspections, customer audits, and corporate assessments as the QRM SME.

Skills

GMP experience

Quality systems & compliance

Risk management knowledge

Cross-functional collaboration

Education

Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related discipline

Job description

Position Summary

The Senior Specialist I/II, Quality Risk Management (QRM) Champion is the Site System Owner for the Quality Risk Management (QRM) Program and Site Risk Register at WuXi XDC Singapore. The role is responsible for maintaining and continuously improving the QRM system, facilitating site-wide risk assessments, providing risk governance and reporting, and ensuring compliance with ICH Q9, FDA, EU GMP, PIC/S GMP, and company quality requirements. The incumbent serves as the site SME for risk management and drives a risk-based quality culture across the organization.

Key Responsibilities

• Own and maintain the site Quality Risk Management (QRM) Program, procedures, templates, and governance processes.
• Serve as System Owner for the Quality Risk Management System and Site Risk Register.
• Facilitate and support cross-functional risk assessments for GMP operations, change controls, deviations, CAPAs, validation, facilities, utilities, computerized systems, warehouse, and QC activities.
• Maintain and monitor the Site Risk Register, including risk escalation, mitigation tracking, and periodic review.
• Provide site-level risk trending, dashboards, metrics, and management review reports to Quality and Site Leadership.
• Ensure risk assessments comply with ICH Q9 principles and support effective risk-based decision making.
• Lead QRM training, coaching, and awareness programs across the site.
• Support regulatory inspections, customer audits, and corporate assessments as the QRM SME.

Qualifications

• Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related discipline.
• 5-8 years of GMP experience within pharmaceutical, biotechnology, biologics, ADC, or CDMO environments.
• Experience in Quality Systems, Quality Assurance, Compliance, Validation, or Risk Management.
• Strong knowledge of ICH Q9, FDA cGMP, EU GMP, PIC/S GMP, Quality Risk Management tools, and GMP quality systems.