Quality Assurance Stream Lead (m/w/d)
Core
Lead quality assurance for complex international customer projects in the pharmaceutical and biotech industry, ensuring GMP compliance and managing quality-related activities.
Role type
Senior Quality Assurance Stream Lead
Builds
Quality assurance processes and documentation for international pharma/biotech clients
Domain
Pharmaceutical manufacturing / Biotechnology / GMP
Required skills
GMP expertise, project management, coordination of QA activities, deviation handling, CAPA management, regulatory compliance, audit preparation, document control
Preferred skills
Veeva Vault experience, change control management, OOX process handling
Responsibilities
Coordinate QA activities with project management, production, and quality control; Plan and moderate QA meetings; Ensure GMP compliance and customer quality agreements; Evaluate and process deviations, change controls, CAPAs, and OOX processes; Support regulatory inquiries and international market requirements; Prepare for and accompany customer audits and regulatory inspections
Seniority
Senior, hands-on IC