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: Consolidated Guideline,” (GCP/GLP’s), supporting a program of quality assurance (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
Conducting the Audit
Liaise with Business Customers and Compliance Partners to Support the Identification & Mitigation of Risk within AGN R&D/MA (Pharma and Med Devices)
Interface with Quality & Compliance Functions
Interface with Regulatory Agencies
Oversee performance and development of GXP auditors
Education and Experience
Proven GXP knowledge through 10 or more years experience of working within the clinical development environment with extensive GCP audit experience
Bachelors degree required
Masters or PhD preferred
Scientific background with demonstrated (ideally ‘hands on’) knowledge of the clinical environment via 1) a drug development role or a 2) regulatory agency inspector role.
Recognized as expert with respect to GCP regulations
Extensive knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
Knowledge/understanding of the approach and perspectives of regulatory agencies.
Demonstrated ability to manage a globally based and culturally diverse organization.
Essential Skills and Abilities
Excellent written and verbal communication skills
Able to interface effectively with senior-level business leaders
Excellent negotiation and relationship building skills
High degree of organizational awareness
People leadership skills
Good understanding of medical /corporate governance principles
Demonstrated ability to develop sound solutions to complex problems