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Compliance Mgr
Job Number:
44074606
Company Name:
Amgen
Job Location:
Seattle, WA US
Job Categories:
Human Resources Legal Services
Compliance Mgr
Compliance Manager position with Amgen Inc., the world's largest biotech, located in Seattle, Washington.
The purpose of this position is to provide independent and objective compliance advice and oversight to the business in support of regulatory filings and key R&D activities and to provide actionable compliance information to management within R&D with focus on Good Laboratory Practices for the support of Amgen's preclinical programs. This position will require 25% to 40% of travel.
Key responsibilities include: •Plan, conduct and report routine and complex compliance audits •Follow-up on corrective actions to resolution •Identify compliance risks •Provide compliance advice to the business to support regulatory filings and other key R&D activities •Participate in departmental projects and initiatives •Represent the department at assigned area meetings •Collaborate with other Amgen compliance functions as appropriate •Assist in Regulatory Agency inspection activities •Support directed compliance audits as needed •Contribute to department SOPs, user manuals, audit checklists and templates •Maintain knowledge of current regulatory, GCP, GLP and/or PV practices/issues as applicable •Represent Amgen on appropriate industry and professional forums •Provide coaching/mentoring to staff •Promote and communicate department role and knowledge
Basic Qualifications Doctorate degree OR Master's degree & 3 years of directly related experience OR Bachelor's degree & 5 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
Preferred Qualifications •1 year of GLP auditing experience •Experience with and application of GLP regulatory requirements •Experience working with GLP auditing principles •Experience with preclinical and translational sciences processes •Master or Bachelor's degree in Science (biology, toxicology, biochemistry, chemistry or related fields preferred) •Experience supporting regulatory authority inspections of preclinical and/or clinical research activities •Knowledge of system and equipment validation principles
With the emphasis on the following key competencies: •Strong verbal and written communication •Ability to work/collaborate efficiently in teams •Ability to manage time well in multi-task/ priority-shifting environment •Great interpersonal skills •Results Oriented •Analytical •Strong leadership abilities •Ability to mentor others
