Responsabilidades

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: Guía consolidada,” (GCP/GLP’s), apoyar un programa de garantía de calidad (control de calidad) 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 & Mitigación de Riesgos dentro de AGN R&D/MA (Dispositivos farmacéuticos y médicos)
Interfaz con la calidad & Funciones de cumplimiento
Interfaz con agencias reguladoras
Oversee performance and development of GXP auditors
Requisitos

Educación y experiencia

Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Licenciatura requerida
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) un papel en el desarrollo de fármacos o un 2) función del inspector de la agencia reguladora.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Conocimiento/comprensión del enfoque y las perspectivas de las agencias reguladoras..
Demonstrated ability to manage a globally based and culturally diverse organization.
Habilidades y habilidades esenciales

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


NB Ciencia

organización de contratos de investigación

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