Manager*in (w/m/d) Qualitätssicherung QA – Klinische Studien im GCP-Umfeld
Core
Ensuring compliance with GCP, ICH guidelines, and FDA regulations for clinical trials through audit support, deviation management, and SOP maintenance.
Role type
Quality Assurance Manager (Clinical Trials)
Builds
Quality assurance processes and compliance frameworks for clinical studies
Domain
Healthcare / Clinical Research / Regulatory Compliance
Required skills
GCP knowledge, ICH guidelines, FDA regulations, deviation management, CAPA processes, SOP creation, audit preparation, stakeholder collaboration
Preferred skills
Clinical monitoring experience, natural sciences/pharmacy/medicine degree, travel readiness
Technologies
GCP, ICH guidelines, FDA regulations
Responsibilities
Support planning and execution of internal/external audits and regulatory inspections, Ensure compliance with GCP and regulatory requirements, Manage deviations and CAPA processes, Create and maintain SOPs and training materials, Collaborate with Clinical Operations and Regulatory Affairs
Seniority
Manager, hands-on IC