Head Of Development Supply Quality

Principal Responsibilities• Lead the Quality / Pharmacy SME team to support the GCS team, providing troubleshooting onclinical programs, expert GCP support for clinical execution, pharmacy manual standards, ISR(investigator sponsored research) and home-dosing programs.• Support the on-time completion of commitments for clinical supply including risk management, changecontrol implementation, deviation/investigation review, and CAPA completion.• Point of escalation for clinical site queries regarding handling and use of investigational product.• Point of escalation for interactive response technology (IRT) issues related to clinical supply.• Provides Quality approval of procedures associated but not limited to: clinical distribution, ISR,comparators and home dosing.• Quality approval of pharmacy manuals, IRT protocol approval and build verification, and distributiondeviation records.• Support inspection readiness and preparedness by ensuring all quality records and documentation arecomplete and provided to clinical supply colleagues.• Create and own of Alexion standards and best practices for clinical supply and execution.Date Posted16-Aug-2024Closing Date30-Aug-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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