Compliance and Safety Manager
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.What you will do
Lets do this. Lets change the world. In this vital role you will lead Amgens drug product technologies (DPT) compliance and audit readiness. You will be accountable for serving every patient every time by transforming drug product processes into reliable and efficient manufacturing operations using advanced scientific and engineering principles. Specifically, the successful candidate will:
Lead and coordinate DPT audit and inspection readiness as well as supporting any audit.
Manage DPT deviations and CAPA records
Ensure compliance with the Amgen Quality Processes
Improve DPTs overall compliance state
Implement and lead the DPT compliance network
Be a change agent for safety and engage with DPT safety forums
Oversee training metrics, job hazard assessments, and training assignment portfolio revisions
Support instrument setup and software configurations to ensure data is stored correctly
Manage people effectively both in direct and indirect reporting structures
Build cross-functional relationships with strategic partners to boost DPTs compliance culture
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an employee with these qualifications.Basic Qualifications:
Masters degree and 3 years of Compliance OR Laboratory experienceOr
Bachelors degree and 5 years of Compliance OR Laboratory experienceOr
Associates degree and 10 years of Compliance OR Laboratory experienceOr
High school diploma / GED and 12 years of Compliance OR Laboratory experienceAnd
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:
Excellent written and verbal communication as well as documentation practices
Experience with closing deviations and CAPAs
Previous experience in either process development or in QC
Previous experience with GMP and GLP facilities
Strong record of cross-functional engagement and productivity
Demonstrated ability as an effective manager of people
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
for a career that defies imagination
Objects in your future are closer than they appear. 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 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.