QA/Compliance Director - GCP Strategy
Amgen - Thousand Oaks, CA

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The Director, Good Clinical Practice (GCP) Strategy, is a global role responsible for providing strategic advice to Development regarding compliance to GCP requirements. The Director is responsible for providing Amgen's interpretation regarding GCPs and GCP compliance requirements, including inputs into Amgen SOPs and training to ensure compliance. The Director is responsible for the development and implementation of the GCP compliance strategy, including contributing to the appropriate planning of audits regarding key GCP issues. The Director is responsible for analyzing audit outcomes/compliance trends to identify areas of risk/exposure; escalating compliance risks to senior management; managing regulatory authority inspections at Amgen related to GCP; and contributing to management and quality reporting regarding GCP compliance.
This position requires 10% travel, domestically and abroad. Basic Qualifications Doctorate degree & 4 years of directly related experience
Master’s degree & 8 years of directly related experience
Bachelor’s degree & 10 years of directly related experience Preferred Qualifications 5+ years of experience and understanding of GCP activities
Ability to develop a GCP compliance oversight program
Quality assurance or compliance experience

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Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...