Senior QA & Validation Leader, GMP & Data Integrity

WuXi XDC; Singapore; On-site; SGD 180,000 - 280,000; Full time

Job summary

WuXi XDC Singapore is seeking a Senior Manager, Quality Engineering to provide strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and QC operations.

This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity, serving as the Site Data Integrity Champion and overseeing qualification, validation lifecycle, and system governance.

Qualifications

• Bachelor's degree in a relevant engineering or life sciences discipline.
• Minimum 10 years in pharmaceutical/biotech/CDMO environments.
• At least 5 years in a leadership role within QA, Validation, Engineering, QC, or related GMP functions.
• Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11, and Data Integrity.

Responsibilities

• Provide strategic and operational quality leadership across Validation, Engineering, Utilities, HVAC, Process Gases, IT/CSV, Warehouse, and QC operations.
• Review deviations, investigations, CAPAs, change controls, QRAs, and validation documents to ensure compliance.
• Lead audits and inspections readiness and represent Quality Operations during client audits and regulatory inspections.
• Develop resource plans, budgets, and KPI dashboards; mentor and coach the Quality Engineering & Support team.
• Collaborate with Engineering, Validation, Manufacturing, Warehouse, QC, Supply Chain, IT, Regulatory Affairs, and global stakeholders to align quality objectives.

Skills

Quality Leadership

GMP Compliance

Data Integrity

Regulatory Liaison

Stakeholder Management

Team Leadership

Risk Management

Education

Bachelor's Degree in Engineering/Life Sciences/Pharmacy

Advanced degree preferred

10+ years pharmaceutical/biotech/CDMO experience

Tools

CSV / Computerized Systems

Quality Management Systems

Validation Lifecycle Management

Job description

WuXi XDC Singapore is seeking a Senior Manager, Quality Engineering to provide strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and QC operations.

This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity, serving as the Site Data Integrity Champion and overseeing qualification, validation lifecycle, and system governance.