Quality Compliance Lead (6-Month Assignment, Wuxi to Singapore)

About the role

The Compliance Lead leads the site Quality Compliance function and ensures a sustainable state of GMP inspection readiness across all quality systems and GMP operations. As the primary site authority for compliance oversight, regulatory intelligence, inspection management, self-inspection programs and compliance risk management, the role drives a proactive quality and compliance culture through governance, trend analysis, continuous improvement and cross-functional partnership. The successful candidate completes a 6-month assignment at the Wuxi China site before returning to Singapore to support XDC Singapore operations.

Key responsibilities

• Lead and manage the full lifecycle of client and regulatory inspections and audits, including pre-inspection readiness, on-site hosting and post-inspection follow-up, CAPA strategy, response drafting and closure tracking.
• Own and lead the site self-inspection program, including annual plans, scopes and schedules, and trend analysis of self-inspection findings to identify systemic issues and inspection readiness gaps.
• Analyze audit, self-inspection and regulatory observations to identify recurring issues, compliance risks and continuous improvement opportunities, and recommend actions to functional owners and senior management.
• Improve audit, inspection and self-inspection processes, tools and templates, and collaborate with cross-functional teams using risk-based and Lean principles.
• Monitor global and local regulatory requirements (FDA, EMA, HSA, ICH, PIC/S), perform gap assessments and drive remediation and compliance actions.
• Track site-level regulatory commitments and authority observations, and provide compliance guidance to site leadership and teams.

Required profile

• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering or a related scientific discipline.
• 10-15 years of experience in QA compliance, quality systems or regulatory compliance in pharmaceutical, biotech or CRDMO environments.
• Proven experience hosting and managing regulatory inspections (FDA, EMA, HSA, PIC/S) and client audits.
• Demonstrated experience owning or leading site self-inspection programs and hands-on experience with CAPAs, audit responses and regulatory commitments.

Required skills

• Strong working knowledge of GMP regulations (FDA 21 CFR Parts 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10).
• Solid understanding of QMS, inspection readiness and risk-based compliance approaches.
• Experience in regulatory monitoring, gap assessment and remediation.
• Excellent technical writing skills for audit reports, inspection responses and CAPA documentation.
• Leadership skills, risk-based thinking and continuous improvement (Lean knowledge is an advantage).