Senior Auditor - GCP and/or Pharmacovigilance
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.Live
What you will do
Lets do this! Lets change the world!Senior Auditor GCP and/or Pharmacovigilance
LIVEWhat you will do
In this vital role within R&D Auditing you will be planning and participating in global audits of Amgens clinical trials and pharmacovigilance activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:
Plan, conduct and report routine and directed GCP and/or PV compliance audits internationally.
Serve as a lead auditor for complex GCP and /or PV audit types
Identify and communicate compliance risks to QA and R&D management
Host and/or play a role in regulatory authority inspections
Contribute to or lead QA process improvement initiatives
Author and contribute to the development of QA cross functional controlled documents
Currently all auditing being conducted remotely, pending easing of travel restrictions the role can entail up to 30% travel to international destinationsBe part of our team
You would be joining Amgens R&D Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgens portfolio in all stages of development and post marketing.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.
Doctorate degree and 2 years of Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector experience
Masters degree and 6 years of Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector experience
Bachelors degree and 8 years of Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector experience
Associates degree and 10 years of Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector experience
High school diploma / GED and 12 years of Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
Experience supporting regulatory authority inspections
Participation in process improvement initiatives.
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.