Senior Quality and Compliance Manager

We 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 role is a critical backfill to maintain business continuity of existing quality operations, including audit management, process governance, and quality oversight. The successful candidate will focus on sustaining and enhancing established quality frameworks, ensuring operational consistency, and supporting audit readiness. Exposure to regulated environments (e.g., GxP/GCP) is advantageous.

Responsibilities

Quality Management System (QMS) Ownership

• 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

Audit & Compliance Management

• 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

Process Governance & Continuous Implementation

• 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
• Provide guidance to stakeholders on quality standards and documentation requirements

Quality Control & Oversight

• 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)
• Monitor quality metrics and support reporting on quality performance
• Provide oversight to ensure consistency and compliance across functions

Training & Advisory

• Support and deliver quality and compliance-related training (e.g., QMS, SOPs, research compliance requirements)
• Act as a point of contact for quality and compliance-related queries
• Provide practical guidance to teams on navigating compliance requirements in day-to-day operations
• Promote awareness and adherence to quality standards across teams

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