Interim QMS & Audit Readiness Consultant (Clinical Research) (f/m/d)

Clariness is looking for an Interim QMS & Audit Readiness Consultant (Clinical Research) (f/m/d).

Contract | 8-Week Engagement | Immediate Start | Remote

About the role: We are a growing company specializing in patient recruitment for clinical trials, partnering with sponsors and CROs to accelerate enrollment across multiple therapeutic areas. Our organization operates under a mature and well-established Quality Management System (QMS) that supports high standards of compliance, operational excellence, and audit readiness. As part of our group structure, we are seeking an experienced external consultant to support our sister company in achieving audit-ready processes aligned with our existing QMS framework. The objective is to formalize, document, and harmonize their operational procedures, particularly within the clinical trial recruitment and patient enrollment environment, ensuring consistency, regulatory compliance, and alignment across the group. This is a focused, execution-driven 8-12 week engagement.

Tasks Your responsibilities:

• 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 (Standard Operating Procedures), 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 and data protection requirements (e.g., GDPR, where applicable), support implementation of document control and training structures, prepare the organization for audit and inspection readiness, provide guidance and practical training to operational teams.

Requirements Your profile:

• 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 (short-term, 8–12 week engagements preferred).
• Experience within patient recruitment or clinical trial support organizations is a strong plus.
• 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.

Benefits Make an impact in healthcare - The speed of bringing needed medical innovation to market still depends on the duration of clinical trials. By globally lowering the barrier for access to clinical trials and increasing the chances to find a treatment for patients, we accelerate medical innovation.

Have we sparked your interest? Would you like to become part of our dynamic, curious, and international culture with plenty of room for your ideas and creativity in an inspiring atmosphere? If so, we look forward to receiving your application with details of your desired salary and possible starting date, preferably via our application portal. Clariness GmbH will treat the above information strictly confidential and will especially observe the applicable provisions of the applicable data protection laws.