Compliance Sr Mgr
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Compliance Senior ManagerLive
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide independent and objective compliance advice and oversight to the business in support GCP and GLP activities in order to strengthen and advance Amgen’s R&D QMS
Assess and manage risk, including providing input into the development of the annual audit program
Collaborate with other Amgen compliance/quality functions to ensure aligned and comprehensive compliance support for R&D GCP, GLP and Research programs
Participate as compliance representative in evaluating, qualifying and providing oversight of GCP/GLP vendors
Participate in due diligence activities for potential business development deals
Ensure escalation of significant compliance matters to appropriate compliance/quality oversight bodies and participate in compliance investigations
Prepare, analyze and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information on periodic basis to key stakeholders and senior R&D management
Maintain knowledge of current regulatory and compliance practices/issues and provide continuous training and education to R&D staff on relevant information
Triage and/or manage as appropriate R&D GCP/GLP compliance matters arising in assigned geographic region
Support activities related to GxP inspections - preparation, conduct and close out and response review
Provide compliance oversight for Amgen programs for all stages of products in clinical and/or laboratory development
Provide ISA, IPA, SPA support pre-meetings, debriefs, Audit plan outlines, response review and risk management
Contribute to Continuous Improvement Initiatives and improve R&D processes by contributing expertise in identifying robust CAPAs
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 a candidate with these qualifications.Basic Qualifications:
Doctorate degree and 2 years of Regulatory & Compliance experienceOr
Master’s degree and 6 years of Regulatory & Compliance experienceOr
Bachelor’s degree and 8 years of Regulatory & Compliance experienceOr
Associate’s degree and 10 years of Regulatory & Compliance experienceOr
High school diploma / GED and 12 years of Regulatory & Compliance experiencePreferred Qualifications:
Degree educated in appropriate subject area with proven experience gained in the biopharmaceutical industry
GCP / GLP Quality Assurance Qualification
Experience supporting regulatory authority inspection of pre-clinical, clinical research, laboratory research and/or pharmacovigilance activities
Compliance programme or project management
Thorough knowledge of GCP / GLP regulations
Understanding of audit/compliance program design
What you can expect of us
As we work to develop treatments that take care of others, we also 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.[Register to View]
If 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.