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Principal Corporate Quality Compliance Auditor

Company: Amgen SA
Location: Los Angeles
Posted on: June 26, 2022

Job Description:

This position can be located remotely within the United StatesHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission"to serve patients"drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together"researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.Principal Corporate Compliance AuditorLiveWhat you will doLet's do this. Let's change the world. In this vital role you will coordinate, lead and participate in audits of Corporate Quality Management Systems, Amgen Sites, Contract facilities, Affiliates, and Critical Service Providers to assess compliance with all applicable domestic and international regulations.Responsibilities:Assess Amgen's state of compliance with applicable regulations and lead / participate in the assessment of action plans to remedy deficiencies.Provides technical support/compliance review of multi-site/global documents resolving compliance issues.Support domestic and international Regulatory Authority Inspections.Collaborate with functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.Serve as Corporate Quality Compliance representative on cross-functional teams (e.g., QMS, GPO and special task forces) and interacts with other departments to achieve goals.Support Continual Improvement initiatives, programs and projects.Partner to resolve deviations, CAPAs, and effectiveness verifications related to Global Quality Compliance.Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines, standards, trends and expectations).Review, provide feedback, and approve audit reports50% Domestic/International travelWinWhat we expect of youBasic Qualifications:Doctorate degree and 2 years of Quality, Regulatory, Compliance or Operations experienceORMaster's degree and 6 years of Quality, Regulatory, Compliance or Operations experienceORBachelor's degree and 8 years of Quality, Regulatory, Compliance or Operations experienceORAssociate's degree and 10 years of Quality, Regulatory, Compliance or Operations experienceOrHigh school diploma / GED and 12 years of Quality, Regulatory, Compliance or Operations experienceWe are all different, yet we all use our unique contributions to serve patients. The Compliance professional we seek is a dynamic individual with these qualifications.Detailed experience and knowledge of partnering with manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, data integrity.Lead auditor certification (i.e. ASQ).Subject matter expert on global regulated requirements.Current up to date knowledge on the latest standards, regulations, and industry trends.Previous mentorship for senior auditing staff.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Keywords: Amgen SA, Los Angeles , Principal Corporate Quality Compliance Auditor, Education / Teaching , Los Angeles, California

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