- 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)
- 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.
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Clinical and Pharmacovigilance Quality USA Lead
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Clinical and Pharmacovigilance Quality USA Lead - Boston, United States - Argenx
Description
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:
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 at Only inquiries related to an accommodation request will receive a response.
Clinical and Pharmacovigilance Quality USA Lead professionals in Boston
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Juntong Chen
Biomedical engineer
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Pranay Gawas
Data Engineer