Responsabilidades
The Director, O GCP será obrigado a supervisionar tudo e participar de, auditoria de garantia de qualidade de todas as atividades sujeitas ao, “Boas Práticas Clínicas/Laboratoriais do ICH: Diretriz Consolidada,” (GCP/GLP), apoiando um programa de garantia de qualidade (Controle de qualidade) 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 & Mitigação de Risco dentro do AGN R&D/MA (Dispositivos farmacêuticos e médicos)
Interface com Qualidade & Funções de Conformidade
Interface com Agências Reguladoras
Oversee performance and development of GXP auditors
Requisitos
Educação e Experiência
Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Necessário diploma de bacharel
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) um papel no desenvolvimento de medicamentos ou um 2) função de inspetor de agência reguladora.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Conhecimento/compreensão da abordagem e perspectivas das agências reguladoras.
Demonstrated ability to manage a globally based and culturally diverse organization.
Habilidades e Habilidades Essenciais
Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
Alto grau de consciência organizacional
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems
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