Principal Responsibilities
• Lead the Quality / Pharmacy SME team to support the GCS team, providing troubleshooting on
clinical 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, change
control 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 distribution
deviation records.
• Support inspection readiness and preparedness by ensuring all quality records and documentation are
complete and provided to clinical supply colleagues.
• Create and own of Alexion standards and best practices for clinical supply and execution.


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.