Senior Clinical QA Manager(m/w/x)

Anforderungen

• Background in Good Clinical Practices
• Master’s degree in scientific discipline
• Knowledge in Quality Assurance and Auditing
• Industry or health authority experience
• Experience in GCP Quality Assurance
• Experience in Clinical Research & Development
• Understanding of ICH-GCP and regulations
• Experience with clinical electronic systems
• Experience in cross‑cultural environments
• Excellent communication skills
• Problem solving and risk management
• Negotiation and influencing capabilities
• Reliability, conscientiousness, and adaptability
• Independent and collaborative work ability
• Ability to travel
• Fluency in English

Aufgaben

• Act as the key quality partner for clinical trial teams
• Provide expert guidance during study planning, execution, and closure
• Ensure compliance with regulatory requirements and Good Clinical Practice
• Collaborate with internal teams and CROs to support trial conduct
• Resolve quality-related questions with internal and external partners
• Identify risks and propose pragmatic solutions
• Escalate significant quality issues when necessary
• Develop and deliver GCP and clinical quality training
• Optimize quality processes, tools, and clinical systems
• Lead health authority inspection preparation and follow-up
• Conduct audits of sites, vendors, and processes
• Oversee corrective actions related to audit findings
• Represent the GCP function in professional networks and meetings
• Maintain high-quality standards to ensure reliable clinical data

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien