11 years of experience in quality and project management for pharma and medical devices.
Expertise in GLP, cGMP, GCP, Pharmacovigilance and GAMP.
Track record in managing international and cross functional projects (e.g. new product development, set up development center and analytical laboratory).
Balance of strategic and operational focus.
Experience with health authority GxP inspections.
Proactive strategic thinker, result-driven, flexible and persistent.
Specialties: Project Management
Management of effective compliance programs
Global vs local
Harmonisation/ standardisation vs customization
Effective stake holder management
Setting priorities based on risk management
Leading i...