Ihre Aufgaben:
* Quality Oversight & Systems Management: Monitor compliance with quality guidelines in clinical business areas and implement regional quality plans
* Identify potential gaps, recommend solutions, and escalate relevant issues
* Assist in maintaining and improving quality documents and processes
* Audit & Inspection: Lead and support audit and inspection preparations, including document management and response coordination
* Ensure trial sites and teams are inspection-ready
* Consultation & Collaboration:Serve as the primary quality consultant, providing guidance on regulatory requirements and risk management
* Support root cause analysis, CAPA processes, and audit planning
* Collaborate with quality teams to strengthen quality culture and resolve issues
* Process Improvement & Metrics: Drive continuous improvement and process optimization
* Analyze quality metrics to identify gaps and recommend corrective actions to enhance compliance and efficiency
Ihre Qualifikationen:
* Education & Experience: Bachelor's degree in science, technology, or healthcare; experience in quality systems within clinical trials is required
* Project Management: Strong ability to prioritize and effectively manage multiple tasks
* Communication: Excellent communication skills and ability to influence various stakeholders
* Analytical Skills: Problem-solving abilities and attention to detail for risk assessment and process optimization
* Teamwork & Flexibility: Independent yet collaborative work style within global teams
* Preferred: Experience in a global quality assurance environment and knowledge of regulatory requirements and clinical trial processes
* German and Englisch fluent
Ihre Vorteile:
* Vacation: 30 days
* Work in an international Company