R&D Quality 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.
Amgens Quality Operations organization serves as a trusted partner to R&D with the responsibility to provide a risk-based Quality Management System (QMS) that is understood and compliant while enabling speed to market and continuous improvement. As a key member of this team, the Senior Manager, Exception Management for Quality, Compliance and Audit will strengthen and advance Amgens R&D QMS, establish strategy for and lead exception management and own the R&D CAPA System (RDCS) and processes. Promoting a culture of proactive process improvement and change, the Senior Manager will:
Function as the Business Process Owner to provide vision, leadership and strategy for QMS and CAPA systems, processes and exception management.
Manage and monitor effectiveness of the R&D CAPA System (RDCS) and work with collaborators to ensure aligned approach to CAPA management and associated regulations.
Lead RDCS evolution strategy and advance system integration activities.
Define strategies and implement processes and tools for mergers and acquisitions, consistent exception data, trend reporting and root cause analyses.
Partner with key team members to ensure aligned approach to CAPA management, provide SME leadership and advice for investigations and root-cause analyses.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.Basic Qualifications
Doctorate degree and 2 years of compliance/quality related experience
Masters degree and 6 years of compliance/quality related experience
Bachelors degree and 8 years of compliance/quality related experience
Associates degree and 10 years of compliance/quality related experience
High school diploma / GED and 12 years of compliance/quality related experiencePreferred Qualifications
Advanced degree, such as an MBA or related field
10+ years in Compliance, Quality and/or other relevant areas in the pharmaceutical/ biotech industry
8+ people leadership and management experience
Expert knowledge of global regulations impacting R&D activities
Experience with Quality Management System oversight and CAPA management
Excellent communication, presentation and project management skills
Expertise in root cause, impact and risk analyses
Strong background in process management
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.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, 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.