Clinical and Pharmacovigilance Quality USA Lead (Director)
Company: argenx SE
Location: Boston
Posted on: May 4, 2024
Job Description:
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:
- A science or healthcare-based degree
- Minimum 7 years clinical trial experience
- At least 5 years of quality assurance experience
- In-depth knowledge of Clinical Trial related US and EU
regulations and ICH GCP Guidelines.
- FDA inspection experience -
- Ability to create a comprehensive study quality oversight plan
and audit program and lead the execution thereof.
- Ability to lead, motivate and educate the clinical study team
on clinical quality aspects.
- Capable of building effective relationships with internal and
external stakeholders.
- Able to operate in a dynamic surrounding of a fast-growing
biotech company with challenging timelines.#LI-Hybrid At argenx we
strive to create a welcoming and inclusive environment. Here all
applicants will receive equal consideration for employment without
discrimination on the basis of race, color, religion, sex, sexual
orientation, gender identity, national origin, protected veteran
status, disability, or any other applicable legally protected
characteristics. argenx is proud to be an equal opportunity
employer.If you require reasonable accommodation in completing your
application, interviewing, or otherwise participating in the
candidate selection process please contact us athr.us@argenx.com .
Only inquiries related to an accommodation request will receive a
response. About Usargenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases and cancer. Partnering with leading academic researchers
through its Immunology Innovation Program (IIP), argenx aims to
translate immunology breakthroughs into a world-class portfolio of
novel antibody-based medicines. argenx is evaluating efgartigimod
in multiple serious autoimmune diseases. argenx is also advancing
several earlier stage experimental medicines within its therapeutic
franchises. argenx has offices in Belgium, the United States,
Japan, and Switzerland.
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Keywords: argenx SE, Brookline , Clinical and Pharmacovigilance Quality USA Lead (Director), Healthcare , Boston, Massachusetts
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