The role is responsible for ensuring products, processes, systems, and supply chains are fully compliant and inspection-ready to support successful commercial launch
Job Summary
The role is responsible for ensuring products, processes, systems, and supply chains are fully compliant and inspection-ready to support successful commercial launch.
Candidates must execute a Quality Commercial Readiness strategy defining criteria across GMP manufacturing and GDP distribution networks.
This position requires deep knowledge of EU GMP, FDA regulations, and global regulatory interactions to manage risks impacting commercial readiness.
Matching Summary
The role is responsible for ensuring products, processes, systems, and supply chains are fully compliant and inspection-ready to support successful commercial launch.
Skills & Requirements
Must-have
GMP and GDP regulatory compliance expertise
Commercial product launch readiness strategy
Cold chain management and distribution oversight
Supply chain risk mitigation and assessment
Serialization and traceability requirements
Nice-to-have
Experience with eQMS systems implementation
Strong stakeholder management in high-pressure environments
Background in mental health treatment development
Familiarity with validation lifecycle IQ OQ PQ
Key Requirements
10+ years experience in Quality within Pharma/Biotech
Bachelor's or Master's degree in Pharmacy, Life Sciences, or Engineering
Contract duration of 9 months
Deep knowledge of EU GMP and FDA 21 CFR Parts 210/211