Compliance Senior Manager (Auditor) -- Global R&D Audit - GCP / PV
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.
Compliance Senior ManagerLive
What you will do
Lets do this. Lets change the world.
This is an exciting opportunity for a Compliance Senior Manager (Auditor) position within Amgen's Global Research and Development Compliance and Audit (GRDCA) team. It is a key Quality Assurance role in the GRDCA organization, with primary responsibility for planning and participating in global GCP and PV audits. The breadth of audits performed include audits of Amgens clinical trials, vendors, internal processes and pharmacovigilance activities. This position can be based at Amgen's corporate headquarters in Thousand Oaks, California or remote. However, the strong preference is that the role be based in Thousand Oaks, CA. The position requires approximately 30% travel to US and international audit Sites, and also supports regulatory inspections of clinical sites and Amgen facilities.
Plan, conduct and report routine and directed clinical trial, GLP and PV compliance audits
Follow-up on corrective actions until resolution
Identify and communicate compliance risks to GRDCA management
Host and/or play a lead role in regulatory authority inspections
Lead GRDCA process improvement initiatives
Author and contribute to the development of GRDCA cross functional controlled documents
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is an employee with these qualifications.Basic Qualifications:
Doctorate degree & 2 years of Regulatory & Compliance experience OR
Masters degree & 6 years of Regulatory & Compliance experience OR
Bachelors degree or & 8 years of Regulatory & Compliance experience OR
Associates degree & 10 years of Regulatory & Compliance experience OR
High school diploma / GED & 12 years of Regulatory & Compliance experience
Bachelors degree in appropriate discipline or equivalent experience
5+ years auditing experience in GCP and/or PV auditing experience a plus
Experience supporting regulatory authority inspections
International auditing experience
Participation in process improvement initiatives Knowledge
Knowledge of regulations applicable to area of technical expertise
General knowledge of clinical development and PV process and operations
Knowledge of audit/compliance program design and audit methodology
Knowledge of GLP/PV and GCP Key Competencies
Verbal and written communication
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.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, 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.