Quality Assurance Compliance Manager

Freelance QA Compliance Manager to support a growing digital health / technology organisation in strengthening and maintaining its quality and compliance framework during a period of growth and change.

• Take ownership of the company's quality and compliance framework across applicable industry standards and GxP requirements
• Lead external audits, surveillance activities, and certification processes from preparation through to closure
• Support customer audits, quality assessments, and vendor qualification activities
• Maintain and continuously improve quality documentation, including SOPs, risk assessments, validation documentation, CAPAs, and related records
• Partner with product, engineering, and operational teams to integrate quality and compliance requirements into existing workflows
• Provide guidance and training to internal stakeholders on quality, compliance, and inspection readiness
• Identify compliance gaps and drive appropriate corrective and preventive actions

• 5+ years of hands-on QA / Quality Compliance experience within digital health, medtech, pharma, or another regulated environment
• Strong knowledge of relevant quality management and information security standards such as ISO 9001 and ISO 27001
• Practical experience with GxP-regulated systems and computerized system validation
• Familiarity with GAMP 5 and applicable regulatory requirements for electronic records and data integrity
• Experience working with clinical or regulated technology environments is highly desirable
• Proven experience preparing for and managing external audits, assessments, and certification activities
• Strong understanding of risk management, CAPA, SOPs, validation, and quality systems
• Excellent communication skills and the ability to work independently across technical and non-technical teams