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Company

Original Job Post

Alexion Pharmaceuticals, Inc. · 3 days ago

Head of Development Supply Quality

New Haven, CT

Full-time

Onsite

Director

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality AssurancePharmacySMEGCP SupportClinical ExecutionClinical SupplyChange ControlCAPAInvestigational ProductIRTQuality ApprovalComparatorsHome DosingInspection ReadinessDocumentation

Required

Lead the Quality / Pharmacy SME team

Provide troubleshooting on clinical programs

Provide expert GCP support for clinical execution

Support pharmacy manual standards

Support ISR (investigator sponsored research) and home-dosing programs

Support on-time completion of commitments for clinical supply

Implement change control

Review deviations/investigations

Complete CAPA (Corrective and Preventive Actions)

Handle clinical site queries regarding investigational product

Handle interactive response technology (IRT) issues related to clinical supply

Provide Quality approval for procedures associated with clinical distribution, ISR, comparators, and home dosing

Provide Quality approval for pharmacy manuals, IRT protocol approval, build verification, and distribution deviation records

Support inspection readiness and preparedness

Ensure completeness of quality records and documentation for inspection readiness

Create and own Alexion standards and best practices for clinical supply and execution

Company

Alexion Pharmaceuticals, Inc.

Glassdoor

3.9

Alexion, AstraZeneca Rare Disease was created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. by AstraZeneca.

Founded in 1992

Cheshire, Connecticut, USA

1,001-5,000 employees

https://alexion.com

H1B Sponsorship

Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (34)

2022 (30)

2021 (26)

2020 (18)