Compliance Senior Manager (Auditor) -- Global R&D Audit - GCP / PV
- Employer
- Amgen
- Location
- Thousand Oaks, CA
- Start date
- Jan 21, 2022
View more
- Discipline
- Administration, Accounting, Regulatory, Legal/Compliance
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
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 Manager
LiveWhat 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 Quality Compliance, R&D Audit team. It is a key Quality Assurance role in the Global Quality Compliance organization, with primary responsibility for planning and participating in global GCP and/or 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 preference is that the role be based in Thousand Oaks, CA. The position requires approximately 25% travel to US and international audit sites ( when travel restrictions lift).
Plan, conduct and report routine and directed clinical trial, GLP and PV compliance audits
Follow-up on audit responses until acceptable corrective actions are agreed
Identify and communicate compliance risks to GQC management
Host and/or play a lead role in regulatory authority inspections as required
Lead GQC process improvement initiatives
Author and contribute to the development of GQC 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
Team work
Motivation skills
Leadership skills
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.comJoin 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.Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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