Senior ATMP-GMP Consultant / Projektmanager (m/w/d)
Core
Senior consultant and project manager leading complex GMP projects in the ATMP (Advanced Therapy Medicinal Products) sector, ensuring regulatory compliance and quality for clients.
Role type
Senior IC GMP Consultant / Project Manager
Builds
GMP-compliant ATMP production processes and qualified systems for pharma/biotech clients
Domain
Life Sciences / Biotechnology / Regulatory Compliance (GMP)
Deliverable
client delivery
Required skills
ATMP-GMP process development, GMP project management, risk analysis, team leadership, regulatory strategy, client acquisition
Preferred skills
Auditor qualification, EU-GMP guidelines expertise, qualification/validation experience
Technologies
GMP regulatory frameworks, ATMP manufacturing processes
Responsibilities
Advise and guide clients on GMP projects from requirement analysis to implementation, lead projects including planning and coordination, provide technical leadership to project teams, conduct risk analyses and assess GMP processes, actively participate in project acquisition
Seniority
Senior, hands-on IC with strategic oversight