Principal Corporate Quality Compliance Auditor
This position can be located remotely within the United States
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Principal Corporate Compliance AuditorLive
What you will do
Lets do this. Lets 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.
- Assess Amgens 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 reports
- 50% Domestic/International travel
What we expect of you
Doctorate degree and 2 years of Quality, Regulatory, Compliance or Operations experience
Masters degree and 6 years of Quality, Regulatory, Compliance or Operations experience
Bachelors degree and 8 years of Quality, Regulatory, Compliance or Operations experience
Associates degree and 10 years of Quality, Regulatory, Compliance or Operations experience
High school diploma / GED and 12 years of Quality, Regulatory, Compliance or Operations experience
We 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.
What you can expect of us
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.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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, Puerto Rico and Canada 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.