GMP Compliance Lead: Inspection Readiness

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 Compliance Lead to head site Quality Compliance, driving GMP inspection readiness across all quality systems and operations. You will partner with cross-functional teams to ensure regulatory compliance and uphold company standards.

You will own inspections, self-inspection programs, CAPA workflows, trend analysis, and continuous improvement of audit practices, while monitoring FDA/EMA-like guidance, and advising site leadership on risk-based

Qualifications

• 10–15 years in QA Compliance or Regulatory Compliance within pharma/biotech/CRDMO
• Experience hosting regulatory inspections (FDA, EMA, HSA, PIC/S)
• Owner or lead of site self-inspection programs
• Hands-on CAPA, audit responses, and regulatory commitments
• Strong GMP knowledge: FDA 21 CFR Parts 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10
• Solid understanding of QMS, inspection readiness, risk-based compliance
• Strong inspection hosting, communication, and stakeholder-management skills

Responsibilities

• Lead and manage the full lifecycle of client and regulatory inspections/audits, including pre-inspection readiness planning, on-site inspection hosting and coordination, and post-inspection activities including observation triage, CAPA strategy development, formal response drafting, submission, and closure tracking
• Act as the primary site focal point for client and regulatory inspections, ensuring consistent, compliant, and confident representation of the site Quality System and operations
• Own and lead the site Self-Inspection Program, including establishing and maintaining a compliant, risk-based self-inspection strategy, developing annual self-inspection plans, and ensuring timely issuance of self-inspection reports and effective follow-up, tracking, and closure of CAPAs
• Perform systematic trend analysis of audit, self-inspection, and regulatory observations, identifying recurring issues, compliance risks, and continuous improvement opportunities within the QMS, and provide actionable recommendations to functional owners and senior management
• Drive continuous improvement of audit, inspection, and self-inspection processes, including optimization of inspection readiness and audit execution models, enhancement of audit and inspection tools, templates, and tracking systems
• Monitor global and local regulatory requirements and inspection trends (e.g., FDA, EMA, HSA, ICH, PIC/S), perform regulatory intelligence monitoring and impact assessments, and lead site-level gap assessments against new or evolving regulatory expectations
• Lead and track site-level regulatory commitments and authority observations, ensuring clear ownership and prioritization, timely and effective remediation, and implementation of lessons learned to sustain inspection readiness
• Provide compliance guidance and advisory support to site leadership and cross-functional teams on audit readiness, self-inspection findings, regulatory risks, and Quality System enhancements

Skills

QA Compliance

Regulatory Compliance

Inspection readiness

CAPA management

GMP knowledge

Regulatory intelligence

Risk-based compliance

Stakeholder management

Education

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

Job description

WUXI XDC Singapore Private Limited is seeking a Compliance Lead to head site Quality Compliance, driving GMP inspection readiness across all quality systems and operations. You will partner with cross-functional teams to ensure regulatory compliance and uphold company standards.

You will own inspections, self-inspection programs, CAPA workflows, trend analysis, and continuous improvement of audit practices, while monitoring FDA/EMA-like guidance, and advising site leadership on risk-based