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FDA Readinesss Consultant – SQM (M/F/D)
Tasks:
Taking over the control tower and operational project management for planning, controlling, and tracking all activities to achieve FDA readiness
Conducting a comprehensive gap analysis of existing SQM processes, procedures, and documentation, including an assessment of the current compliance situation and defining appropriate corrective and improvement measures for the sites within the scope
Developing and coordinating a structured action plan to close identified gaps, taking into account regulatory requirements and internal quality standards
Close collaboration with the participating sites, quality organizations, and relevant stakeholders to ensure consistent implementation of the defined measures
Regularly monitoring progress, identifying potential risks, and escalating critical issues within the program
Providing expert advice regarding identified SQM gaps, regulatory expectations, and best-practice approaches for the sustainable improvement of supplier quality processes
Supporting the revision, harmonization, and creation of relevant SQM documents Work instructions and process descriptions
Preparation and support of readiness assessments and mock audits to verify the implementation status and effectiveness of implementet measures
Creation of regular status reports and management updates to transparently present project progress, risks, and achieved milestones
Qualification:
experienced consultant with in-depth expertise in the field of medical devices, FDA requirements and supplier quality management
provide both strategic and operational support and has proven experience in complex transformation and compliance projects
Requirements:
Start: 20.07.2026
Duration: 6 months
Capacity: 5 days per week
Location: Germany
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