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Compliance Manager

Thousand Oaks, CA

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The breadth of audits performed include audits of Amgenu00e2u20acu2122s clinical trials, vendors, internal processes and pharmacovigilance activities.Ideally, this position will be based at Amgen's Thousand Oaks offices but can also be based remotely.Approximately 30-40% travel to US and international audit Sites, and may also support regulatory inspections of clinical sites and Amgen facilities.Key responsibilities include:Plan, conduct and report routine GCP and PV compliance audits. Identify and communicate compliance risks to Quality Compliance and Audit managementBasic Qualifications: Doctorate degree OR Master's degree and 3 years of Compliance experienceOR Bachelor's degree and 5 years of Compliance experienceOR Associate's degree and 10 years of Compliance experienceOR High school diploma / GED and 12 years of Compliance experiencePreferred Qualifications:Bachelor degree and 4 years of Biopharmaceutical experience and a minimum of 2 years of experience as a PV/GCP auditorExperience supporting regulatory authority inspectionsInternational auditing experienceParticipation in process improvement initiativesKnowledge of regulations applicable to area of technical expertiseKnowledge of clinical development and PV process and operationsAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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