المسؤوليات

The Director, GCP will be required to oversee all and participate in, quality assurance auditing of all activities subject to the, “ICH Good Clinical/Laboratory Practice: الدليل الموحد,” (GCP/GLP’s), دعم برنامج ضمان الجودة (سؤال وجواب) to ensure that Allergan project data and summary statements are of known and documented quality. Additional responsibilities include consultation and advice with respect to GXP regulations to R&D/MA business partners and leading the AGN team of GXP auditors.

Summary of responsibilities:

Audit of Activities and Vendors Subject to GXP regulations
Audit Planning
Conducting the Audit
Follow-Up
Liaise with Business Customers and Compliance Partners to Support the Identification & التخفيف من المخاطر داخل AGN R&د / ماجستير (فارما وأجهزة ميد)
واجهة مع الجودة & وظائف الامتثال
التفاعل مع الوكالات التنظيمية
Oversee performance and development of GXP auditors
متطلبات

التعليم و الخبرة

Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
درجة البكالوريوس المطلوبة
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) دور تطوير المخدرات أو أ 2) دور مفتش الوكالة التنظيمية.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
معرفة / فهم نهج ووجهات نظر الهيئات التنظيمية.
Demonstrated ability to manage a globally based and culturally diverse organization.
المهارات والقدرات الأساسية

Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
درجة عالية من الوعي التنظيمي
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems


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