HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Live
What you will do
Lets do this! Lets change the world!Responsibilities
The role of the GXP Compliance Manager is to support the provision of proactive GxP compliance oversight and guidance to functional areas and partner groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GxP Compliance.This includes:
Entering and updating records in RDCS based on investigation and exception meetings and tracking through to closure
Supporting GCF Level 6 investigation lead in RCA & effectiveness verification activities of CAPAs
Collating and verifying objective evidence for inspection & audit-driven CAPAs
Assessing quality and accuracy of data in RDCS and reporting on RDCS status, progress and activities, as required based on regulations and guidance from GCF Level 6
Data entry into the risk assessment tool (using risk assessment methodology)
Support Safety, Global Development and Global Research teams in GxP inspection readiness and inspection management activities
Support R&D Compliance on governance bodies in the clinical development, pharmacovigilance and/or research area
Support the GxP compliance team as needed with functional activities including exception management, inspection readiness, administration of compliance committees
Maintain knowledge of current regulatory and compliance practices/issues
Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key partners
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.
Masters degree and 3 years of compliance experience
Bachelors degree and 5 years of compliance experience
Associates degree and 10 years of compliance experience
High school diploma / GED and 12 years of compliance experience
Minimum 4 years in biopharmaceutical industry
Minimum 2 years in GxP compliance
Experience in exception management (include RCA) in a GxP setting
Experience supporting regulatory authority inspections of GxP (e.g.clinical research, pharmacovigilance) activities
Participation in process improvement initiatives
Knowledge of global GxP regulations
Knowledge of regulatory authority inspection processes
General knowledge GxP processes and operations in the bio-pharmaceutical industry
Understanding of audit/compliance program design
GxP Quality Assurance Qualification/Certification (recommended)
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. 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.