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Clinical and Pharmacovigilance Quality USA Lead (Director) - Boston Massachusetts
Company: argenx SE Location: Boston, Massachusetts
Posted On: 05/05/2024
Clinical and Pharmacovigilance Quality USA Lead (Director) page is loaded Clinical and Pharmacovigilance Quality USA Lead (Director) Apply locations Boston time type Full time posted on Posted 2 Days Ago job requisition id REQ-2626 To further strengthen our Quality team, we are looking for an experienced and motivated lead, GCP & PV Quality to provide GCP Quality support to argenx programs and clinical trial teams and support Quality Assurance with setting up our Quality Management Systems.Roles and Responsibilities: - Lead as the primary Quality point of contact for the assigned clinical trials.
- Provide GCP QA guidance to the CTT (Clinical Trial Team) to ensure clinical trials are executed in compliance with GCPs, regulatory requirements and argenx processes.
- Lead the GCP quality oversight for assigned clinical trials in close collaboration with CTT(s).
- Manage the clinical trial audit programs; lead the audit site selection process for study specific audit plans in collaboration with the CTT(s) and oversee the timely audit conduct, reporting, review, and closeout in accordance with argenx processes.
- Oversee or lead the GCP vendor(s) qualification/re-qualification as applicable.
- Participate in/lead GCP audits.
- Produce in close collaboration with CTT (s) GCP quality system metrics allowing real-time quality monitoring and reporting (e.g. audits, deviations, CAPAs); conduct their trend analysis for management reporting.
- Drive the investigation of trial quality events and the definition of necessary corrective and preventive measures.
- Lead clinical trial inspection readiness activities.
- Provide QA input during the creation/revision of argenx clinical procedural documents by reviewing them for GCP compliance. When assigned as "QA Approver" in ARGO, act as QA approver for GCP area.
- Lead in regulatory inspections
- Oversee the relationship and performance of our clinical partners/ vendors
- Mentor and coach other team members
- Provide metrics and trends for continuous improvement and share lessons learned and best practices among other CTT(s)Education, Experience and Qualifications:
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