Head of Development Supply Quality

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.

Date Posted

16-Aug-2024

Closing Date

30-Aug-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.