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Compliance Senior Manager - Business Process Management (BPM)
at Amgen Inc.
The Senior Manager role is a global role and reports to the Director of Business Process Management.
•Contribute to and implementing strategy for R&D process management, modeling and change control
•Implement standards to create, manage and control process maps as key Amgen business assets
•Lead process identification and definition efforts in R&D to ensure end-to-end process mapping and identification of potential failure points and risks
•Contribute process modeling and process management expertise to support R&D business process owners
•Lead targeted process reviews and process improvement efforts
•Identify, establish and implement end to end process hierarchy and process management system
•Identify and define process changes required to address incidents / exceptions and inspection findings•Lead and assure robust process change control mechanisms for R&D
•Implement and ensure adherence to Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN)
•Prepare for and contribute to R&D QMS Management Oversight reviews•Manage change control activities within the BPMS for R&D process models
•Lead cross-functional process improvement activities to address major deficiencies / gaps
•Review process models and oversee acceptance into BPMS
Doctorate degree and 2 years of Regulatory & Compliance experience
Master s degree and 6 years of Regulatory & Compliance experience
Bachelor s degree and 8 years of Regulatory & Compliance experience
Associate s degree and 10 years of Regulatory & Compliance experience
8+ years in Quality Management, Process Management, Compliance, or other relevant area of pharmaceutical/biotech industry
Process management and modelling experience
Continuous Improvement and change management expertise
Working knowledge of global regulations impacting R&D activities
Quality Management System oversight & implementation
Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN) Technical expertise
Continuous Improvement (e.g. Lean, 6 Sigma)
Global business acumen
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.