Responsabilità
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: Linee guida consolidate,” (GCP/GLP’s), Supportare un programma di garanzia della qualità (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 & Mitigazione del rischio all'interno di Agn R&D/ma (Dispositivi farmaceutici e medici)
Interfaccia con la qualità & Funzioni di conformità
Interfaccia con le agenzie di regolamentazione
Oversee performance and development of GXP auditors
Requisiti
Istruzione ed esperienza
Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Richiesta di laurea
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) un ruolo di sviluppo di farmaci o a 2) Ruolo dell'ispettore dell'agenzia normativa.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Conoscenza/comprensione dell'approccio e delle prospettive delle agenzie di regolamentazione.
Demonstrated ability to manage a globally based and culturally diverse organization.
Abilità e capacità essenziali
Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
Alto grado di consapevolezza organizzativa
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems
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