Directeur, GCP

Responsabilités

The Director, GCP devra superviser tout et participer, Audit d'assurance qualité de toutes les activités soumises à, « Ich bonne pratique clinique / laboratoire: Directive consolidée, » (GCP / GLP’s), Soutenir un programme d'assurance qualité (QA) 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 & Atténuation du risque dans AGN R&D/MA (Appareils pharmaceutiques et MED)
Interface avec la qualité & Fonctions de conformité
Interface avec les agences de réglementation
Oversee performance and development of GXP auditors
Exigences

Éducation et expérience

Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Baccalauréat requis
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) un rôle de développement de médicaments ou un 2) rôle d'inspecteur de l'agence de réglementation.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Connaissance / compréhension de l'approche et des perspectives des agences de réglementation.
Demonstrated ability to manage a globally based and culturally diverse organization.
Compétences et capacités essentielles

Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
Degré élevé de conscience organisationnelle
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems