Jobfoundry
Jobfoundry
A*STAR

Senior Quality & Compliance Manager

A*STAR
ResearchSingaporeOnsitePosted 5 days ago
Apply Now

About the role

AI summarised

Senior-level role owning the ISO 9001 Quality Management System for a regulated environment. Responsible for maintaining QMS platforms, planning and executing internal/external audits, managing CAPA, driving process governance, and delivering compliance training across research and operational teams.

ResearchOnsite

Key Responsibilities

  • Own and maintain the organisation’s QMS in alignment with ISO 9001 standards
  • Act as the system owner for QMS platforms, including workflow, document control, and training systems
  • Ensure effective management of QMS documentation and training records, supporting applicable research and regulatory compliance requirements
  • Plan and execute internal audits to assess compliance with ISO standards, internal policies, and applicable regulatory requirements
  • Support external audits, including ISO 9001 surveillance and recertification audits
  • Support research-related compliance monitoring and audits (e.g., IRB readiness, study governance where applicable)
  • Manage audit findings, including CAPA tracking, root cause analysis, and timely closure
  • Maintain and enforce standardised processes across the organisation
  • Ensure processes are aligned with applicable compliance requirements (e.g., IRB protocols, data protection, material handling)
  • Identify process gaps and drive continuous improvement initiatives
  • Perform periodic QC checks and reviews to ensure adherence to defined standards and regulatory requirements
  • Conduct targeted compliance reviews across key domains (e.g., IRB/ethics, laboratory activities, export control, and data protection/PDPA)

Requirements

  • 7 – 10 years of experience in quality, compliance, or audit roles
  • Proven experience managing or supporting ISO 9001 QMS and audit cycles
  • Hands-on experience in internal audits, CAPA management, and process governance
  • Exposure to regulated environments (e.g., GxP/GCP) is a plus but not mandatory
  • Bachelor’s degree in Life Sciences, business, or a related field
  • Professional certifications such as ISO 9001 Lead Auditor are preferred
  • Strong knowledge of QMS frameworks and audit methodologies
  • Experience with QMS/document management systems
  • Detail-oriented with strong analytical and problem-solving skills
  • Ability to operate independently and maintain existing systems with minimal oversight
  • Effective communication and stakeholder management skills