Senior Quality Engineering & Compliance Leader

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

The Senior Manager, Quality Engineering & Support at WUXI XDC Singapore Private Limited will provide strategic and operational quality leadership across Validation, Engineering, Utilities, HVAC, Process Gases, IT/CSV, Warehouse and QC operations. This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity requirements.

You will lead qualification/validation oversight, system lifecycle management, risk management and continuous improvement while safeguarding

Responsibilities

• Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations.
• Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards.
• Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance.
• Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (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.
• Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement.
• Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation.
• Review and approve validation protocols, reports, qualification documents, and associated quality records.
• Provide quality oversight for engineering changes and lifecycle management of GMP infrastructure and systems.
• Ensure facilities, utilities, and computerized systems remain in a validated and compliant state.
• Provide quality oversight for warehouse operations, including material receipt, storage, dispensing, inventory management, and distribution activities.
• Support material disposition and release decisions impacting GMP operations.
• Provide quality oversight for QC operations, including laboratory investigations, OOS/OOT events, CAPAs, and change controls.
• Ensure warehouse and laboratory operations remain inspection-ready and compliant.
• Serve as the Site Data Integrity (DI) Champion.
• Lead and maintain the site's Data Integrity Governance Program.
• Promote and embed ALCOA+ principles across the organization.
• Review and approve Data Integrity Risk Assessments, gap assessments, and remediation plans.
• Drive Data Integrity training, compliance monitoring, and continuous improvement programs.
• Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRA), gap assessments, SOPs, protocols, validation documents, and technical reports.
• Ensure quality risk assessments and compliance assessments are scientifically sound and aligned with ICH Q9 principles.
• Lead remediation activities and monitor effectiveness of corrective and preventive actions.
• Provide quality oversight and decision-making for quality and compliance risks.
• Lead, coach, develop, and retain a high-performing team.
• Develop department resource plans to support business growth, site expansion, project execution, and operational demands.
• Manage staffing, succession planning, talent development, and organizational capability building.
• Oversee project timelines, quality deliverables, departmental KPIs, strategic initiatives, and compliance objectives.
• Manage departmental budget planning and resource allocation to support operational and business objectives.
• Collaborate with Engineering, Validation, Manufacturing, Warehouse, QC, Supply Chain, IT, Regulatory Affairs, and global stakeholders to ensure alignment on quality and compliance expectations.
• Support site expansion, technology transfer, validation programs, digitalization initiatives, and business growth activities.

Job description

The Senior Manager, Quality Engineering & Support at WUXI XDC Singapore Private Limited will provide strategic and operational quality leadership across Validation, Engineering, Utilities, HVAC, Process Gases, IT/CSV, Warehouse and QC operations. This role ensures compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines and Data Integrity requirements.

You will lead qualification/validation oversight, system lifecycle management, risk management and continuous improvement while safeguarding