Compliance Sr Mgr
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!
- To provide independent and objective compliance advice and oversight to the business in support of GCP activities
- Strengthen and advance Amgens R&D QMS
- Provide compliance oversight for Amgen programs for all stages of products in clinical development
- Provide ISA, IPA, SPA support pre-meetings, debriefs, Audit plan outlines, response review
- Contribute to Continuous Improvement Initiatives
- Improve R&D processes by contributing expertise in identifying robust CAPAs
- Arrive at long-term remediations and process improvements through RCAs
- 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 and GCP
- Participate as compliance representative in evaluating, qualifying and providing oversight of GCP 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 QCA staff on relevant information
- Triage and/or manage as appropriate R&D/GCP compliance matters arising in assigned geographic region
- Support activities related to inspections - preparation, conduct and close out and response review
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.Experience
Doctorate degree and 2 years of compliance experience
Masters degree and 4 years of compliance experience
Bachelors degree and 6 years of compliance experience
Associates degree and 10 years of compliance experienceOr
High school diploma / GED and 12 years of compliance experience.
- Minimum 7 years in biopharmaceutical industry
- Minimum 5 years in GCP compliance
- Experience supporting regulatory authority inspections of pre-clinical, clinical research, and/or pharmacovigilance activities
- Compliance program or project management
- Participation in process improvement initiatives
- Leadership or mentoring experience Knowledge
- Thorough knowledge of GCP
- Knowledge of global GCP regulations
- Knowledge of regulatory authority inspection processes
- General knowledge of pre-clinical, clinical development, and GCP process and operations in the bio-pharmaceutical industry
- Understanding of audit/compliance program design
- Basic knowledge of at least one other GxP in addition to GCP (recommended)
- Up to 20% of time worked
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.