QA Compliance & Inspection Leader — GMP Excellence

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

Job summary

Wuxi XDC Singapore Private Limited is seeking a QA Compliance Lead to ensure site readiness for regulatory inspections and client audits. You will own the self-inspection program, monitor GMP compliance, and act as the primary liaison for regulators and customers.

The role requires extensive experience in QA, regulatory affairs, and hands-on CAPA management, with a focus on continuous improvement of the Quality Management System.

Qualifications

• Bachelor's degree or above in pharmaceutical sciences or related field.
• 10–15 years' experience in QA compliance, quality systems, or regulatory compliance.
• Proven experience hosting regulatory inspections (FDA, EMA, HSA, PIC/S) and client audits.
• Demonstrated ownership of site self-inspection programs.
• Hands-on CAPA, audit responses, and regulatory commitments management.
• Strong knowledge of GMP regulations (FDA 21 CFR 210/211, EU GMP, PIC/S, ICH).
• Solid understanding of QMS, inspection readiness, and risk-based compliance.

Responsibilities

• Lead and manage the full lifecycle of regulatory authority and client inspections/audits.
• Act as primary site focal point for regulators and client audits.
• Own the site Self-Inspection Program and annual inspection plans.
• Perform trend analysis of audit data to identify systemic weaknesses.
• Monitor global/regional regulatory requirements and inspection trends.
• Serve as quality liaison for clients and provide audit support.
• Oversee project-related quality events (deviations, changes, CAPAs).
• Coordinate cross-functional resources to support GMP execution.
• Advise site leadership on inspection readiness and risk mitigation.
• Perform other compliance-related duties as directed.

Skills

QA Compliance

Quality Systems

Regulatory Compliance

Inspection hosting

CAPA management

Risk-based compliance

Technical writing

Stakeholder management

Education

Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related discipline

Job description

Wuxi XDC Singapore Private Limited is seeking a QA Compliance Lead to ensure site readiness for regulatory inspections and client audits. You will own the self-inspection program, monitor GMP compliance, and act as the primary liaison for regulators and customers.

The role requires extensive experience in QA, regulatory affairs, and hands-on CAPA management, with a focus on continuous improvement of the Quality Management System.