Sorumluluklar
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: BirleÅŸtirilmiÅŸ Kılavuz,” (GCP/GLP’s), bir kalite güvence programını desteklemek (KG) 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 & AGN R Kapsamında Riskin Azaltılması&D/MA (İlaç ve Med Cihazları)
Kaliteyle Arayüz & Uyumluluk İşlevleri
Düzenleyici Kurumlarla Arayüz
Oversee performance and development of GXP auditors
Gereksinimler
EÄŸitim ve Deneyim
Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Lisans derecesi gerekli
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) ilaç geliÅŸtirme rolü veya 2) düzenleyici kurum müfettiÅŸi rolü.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Düzenleyici kurumların yaklaşımı ve bakış açıları hakkında bilgi/anlayış.
Demonstrated ability to manage a globally based and culturally diverse organization.
Temel Beceriler ve Yetenekler
Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
Yüksek derecede organizasyonel farkındalık
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems
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