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Open nowPosted 4 days ago

Quality Compliance Lead

WUXI XDC SINGAPORE PRIVATE LIMITED

Pay
SGD 12,000 – SGD 15,000 a Monthly
Where
Central, Singapore
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Your applicationOpen nowQuality Compliance LeadWUXI XDC SINGAPORE PRIVATE LIMITED · Central, Singapore

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The clock on this job

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12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 4 days ago

The posting

About the role

The Compliance Lead is responsible for leading the site Quality Compliance function and ensuring a sustainable state of GMP inspection readiness across all quality systems and GMP operations. The role serves as the primary site authority for compliance oversight, regulatory intelligence, inspection management, self-inspection programs, and compliance risk management. The Compliance Lead drives a proactive quality and compliance culture through effective governance, trend analysis, continuous improvement initiatives, and cross-functional partnership to ensure compliance with applicable regulatory requirements and company standards.

Key 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

About you

  • 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 within pharmaceutical, biotech, or CRDMO environments
  • Proven experience hosting and managing regulatory inspections (e.g. FDA, EMA, HSA, PIC/S) and client audits
  • Demonstrated experience as owner or lead of site self-inspection programs
  • Hands-on experience managing CAPAs, audit responses, and regulatory commitments
  • Strong working knowledge of GMP regulations and guidelines including FDA 21 CFR Parts 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10
  • Solid understanding of Quality Management Systems (QMS), inspection readiness, and risk-based compliance approaches
  • Strong inspection hosting, communication, and stakeholder-management skills, with the ability to interact confidently with regulators and clients
  • Ability to analyze inspection and audit observations, identify systemic issues, and propose practical, sustainable improvements
  • Excellent technical writing skills, particularly for audit reports, inspection responses, and CAPA documentation

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