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Senior Manager - Business Process Management R&D
at Amgen Inc.
Senior Manager Business Process Management R&D Quality
The Business Process Management R&D Quality team is part of the Global Quality, Compliance, Audit, Learning & Performance (QCAL&P) team for all of Amgen R&D. The team plays a unique and vital role to enable all of R&D with robust process design and delivery of essential Quality Management components including process ownership, risk assessment, metrics and continuous improvement.
The successful Senior Manager Business Process Management will lead identification of end-to-end processes for R&D, drive definition, management and ownership of R&D processes through process modelling, process based risk assessments for assigned business area whilst driving process excellence across R&D.
You will act as a Quality Lead for large change initiatives, providing Quality deliverables and oversight from start to finish on each project.
- Contribute to and implementing strategy for R&D process management, modelling 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 modelling 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
Degree educated with extensive Regulatory & Compliance experience
Proven experience within:
- Quality Management, Process Management, Compliance within pharmaceutical industry
- Continuous Improvement (eg Lean, 6 Sigma) and change management experience
- Process management and modelling experience
- Working knowledge of global regulations impacting R&D activities
- Quality Management System oversight & Implementation
- Business Process Management Standards (BPMS) and Business Process Management Notation (BPMN) Technical expertise
- Global Business acumen
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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 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.