Senior Global Quality Compliance Auditor
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Specialist Quality ComplianceLive
What you will do
Lets do this! Lets change the world!
Responsible for executing Corporate Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:
Coordinates and leads or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.
Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.
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 and standards, trends and expectations, as applicable).
Has documented experience and working knowledge of Amgens competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, and medical devices.
Provides leadership toward escalating site and multi-site compliance issues resulting from audit findings.
Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable.
Provides support for domestic and international Regulatory Authority Inspections whennecessary.
Providestechnicalsupport/compliancereviewofmulti-site/globaldocumentsresolving complianceissues, if/when necessary.
InteractswithotherfunctionalleadstoensurethatAmgenStandards, strategiesanddirectionare alignedwithexistingregulationsandregulatoryexpectations.
Alertssenior and/or executivemanagementofsignificantquality,andcompliancerisks.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Outstanding professional we seek will have these qualifications.Basic Qualifications:
Master's degree and 3 years of compliance experience
Bachelor's degree and 5 years of compliance experience
Associate's degree and 10 years of compliance experience
Highschool diploma / GED and 12 years of compliance experienceThrive
Some of the vast rewards of working here
As 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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.