职责
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: 综合指南, » (GCP/GLP’s), 支持质量保证计划 (质量保证) 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 内的风险缓解&数据/MA (制药和医疗器械)
与质量的接口 & 合规职能
与监管机构的联系
Oversee performance and development of GXP auditors
要求
教育背景和经验
Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
需要学士学位
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) 药物开发角色或 2) 监管机构检查员的角色.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
了解/理解监管机构的方法和观点.
Demonstrated ability to manage a globally based and culturally diverse organization.
基本技能和能力
Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
高度的组织意识
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems
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