Conduct a structured Gap Analysis against regulatory and audit requirements
Review and align sister company processes with our mature QMS framework
Document and formalize operational processes within patient recruitment and clinical trial support functions
Develop and/or refine Quality Manual, SOPs, Work Instructions, Process Maps, Training documentation and records, Deviation and CAPA procedures, Vendor qualification and oversight procedures and Document control systems
Ensure alignment with: ICH-GCP principles, Data protection requirements, support implementation of document control and training structures, prepare the organization for audit and inspection readiness, provide guidance and practical training to operational teams

5+ years of experience in Clinical Quality Assurance, QMS implementation, or Regulatory Compliance
Proven track record of building, formalizing, or harmonizing QMS frameworks
Strong expertise in SOP drafting and structured quality documentation
Hands-on experience preparing organizations for audits and inspections
Experience within patient recruitment or clinical trial support organizations
Strong stakeholder interviewing and process-mapping skills
Ability to quickly assess complex environments and bring structure
Self-driven, hands-on mindset with the ability to deliver within tight timelines
Comfortable working independently in an interim, high-impact role

Make an impact in healthcare
The speed of bringing needed medical innovation to market depends on the duration of clinical trials
Plenty of room for your ideas and creativity in an inspiring atmosphere

Interim QMS, Audit Readiness Consultant – Clinical Research

Key skills