Senior Validation & Quality Engineering Leader

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 140,000 - 210,000; Full time

Job summary

WUXI XDC Singapore Private Limited seeks a Lead, Quality Engineering & Support to provide strategic and operational quality leadership across validation, engineering, utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse and Quality Control.

This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity, acting as DI Champion and driving risk-based improvements.

Qualifications

• Bachelor's degree in a relevant discipline.
• 10+ years in pharmaceutical/biotech/CDMO environments.
• 5+ years of leadership in GMP functions.
• Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
• Expertise in validation lifecycle management and GMP quality systems.

Responsibilities

• Provide quality oversight for validation, engineering, utilities, HVAC, process gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations.
• Ensure SOPs, Quality Risk Assessments, reports, specifications and quality records comply with GMP and data integrity requirements.
• Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance.
• Review and approve deviations, investigations, CAPAs, change controls, QRAs, gap assessments, SOPs, protocols, validation documentation, and technical reports.
• Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections.
• Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation.
• Serve as the Site Data Integrity (DI) Champion and lead the site's Data Integrity Governance Program.
• Promote and embed ALCOA+ principles across the organization.
• Lead remediation activities and monitor effectiveness of corrective and preventive actions.
• Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement.

Skills

Quality leadership

Regulatory compliance

Quality risk management

Data integrity

Audit readiness

Stakeholder management

Decision making

Problem-solving

Education

Bachelor's degree (Engineering/Life Sciences/Biotech/Pharma/CS)

Tools

CSV systems experience

Job description

WUXI XDC Singapore Private Limited seeks a Lead, Quality Engineering & Support to provide strategic and operational quality leadership across validation, engineering, utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse and Quality Control.

This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity, acting as DI Champion and driving risk-based improvements.