Senior Quality Risk Management Champion — Site SME

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

Job summary

WuXi XDC Singapore is seeking a Senior Specialist I/II, Quality Risk Management (QRM) Champion to lead the QRM program and site risk governance. You will own the QRM system, facilitate site-wide risk assessments, and provide risk metrics and reporting to Quality and Site Leadership.

The role requires a life sciences or engineering degree with 5–8 years of GMP experience and strong knowledge of ICH Q9 and global GMP frameworks.

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.

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

Quality Systems

Quality Assurance

Compliance

Validation

Risk Management

Education

Bachelor's degree in Life Sciences / Pharmacy / Chemistry / Biotechnology / Engineering

Job description

WuXi XDC Singapore is seeking a Senior Specialist I/II, Quality Risk Management (QRM) Champion to lead the QRM program and site risk governance. You will own the QRM system, facilitate site-wide risk assessments, and provide risk metrics and reporting to Quality and Site Leadership.

The role requires a life sciences or engineering degree with 5–8 years of GMP experience and strong knowledge of ICH Q9 and global GMP frameworks.