About the role
AI summarisedWe are seeking an experienced Quality & Compliance professional to take ownership of our Quality Management System (QMS) and ensure continued compliance with ISO 9001 standards. This critical backfill role maintains business continuity of existing quality operations, focusing on audit management, process governance, and quality oversight.
ResearchOnsite
Key Responsibilities
- Own and maintain the organization’s QMS in alignment with ISO 9001 standards.
- Plan and execute internal audits to assess compliance with ISO standards, internal policies, and regulatory requirements.
- Support external audits, including ISO 9001 surveillance and recertification audits.
- Manage audit findings, including CAPA tracking, root cause analysis, and timely closure.
- Maintain and enforce standardized processes across the organization aligned with compliance requirements.
- Conduct targeted compliance reviews across key domains (e.g., IRB/ethics, laboratory activities, data protection/PDPA).
- Support and deliver quality and compliance-related training on QMS, SOPs, and research compliance requirements.
- Provide guidance to stakeholders on quality standards, documentation, and navigating compliance in daily operations.
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.
- Bachelor’s degree in Life Sciences, business, or a related field.
- 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.