Development Quality Assurance Manager [Radiopharmacy QA]
Core
Ensure qualification activities and oversight of global and local Radiopharmacies (Site and Central) comply with regulatory requirements (GCP, GMP, PV) and Novartis standards.
Role type
Senior Quality Assurance Manager (Radiopharmacy)
Builds
Qualified and compliant Radiopharmacies for clinical research and development
Domain
Pharmaceutical industry, Radiopharmacy, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Radiopharmacy qualification and oversight, GCP/GMP/PV compliance, risk management, audit and inspection readiness, SOP development, vendor/external service provider management, project leadership
Preferred skills
Experience in radioligand environment (Blood Bank, Tissue Bank, Nuclear Medicine), stakeholder management
Technologies
GCP, GMP, PV, ICH guidelines, UQAP, KQIs
Responsibilities
Oversee implementation and monitoring of Radiopharmacies globally; manage qualification and requalification of external service providers; identify and mitigate quality risks; support audit and inspection readiness; develop and maintain SOPs; drive continuous improvement and CAPA for quality issues.
Seniority
Senior, hands-on IC
