Director, R&D Process Quality Business Intelligence & Data Analytics

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Requirements:

• Doctorate degree and 4 years of quality experience OR Master’s degree and 8 years of quality experience OR Bachelor’s degree and 10 years of quality experience
• 4 years experience directly managing people and leadership experience leading teams, projects, programs, or directing the allocation of resources.
• 15 years or more experience in Quality Management, Quality Assurance, Continuous Improvement, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.
• Thorough understanding of Clinical R&D activities and Global Regulations.
• Well versed in the development of quality measures including their creation and usage in a complex, cross-functional/matrixed environment.
• Strong analytical capabilities - experience with process monitoring, including the application of advanced analytical methods and modern technology used to enable signal detection and quality improvement (e.g., Spotfire, PowerBI, Python).

Responsibilities:

• Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for Amgen R&D.
• Provide strategic leadership in developing and implementing systematic methods to measure and improve R&D quality, ensuring alignment of all data analytics and business intelligence initiatives with broader organizational goals and evolving regulatory requirements.
• Ensure People, Processes, Systems, Data Analytics and Innovation are used effectively to move Quality Culture towards a proactive predict and prevent culture.
• Effectively lead, collaborate and partner with internal R&D team members to analyze and resolve issues and risks to drive clear scope, sponsorship, planning and execution.
• Lead and support management directed data driven projects that are of large impact/scope and thus risk for Amgen clinical trials and pre-clinical research activities.
• Support Amgen’s procedural framework through the development, maintenance, and communication of procedural performance measures/indicators; ensure that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; so that Amgen treats all research subjects ethically and safely, and all data is generated with full integrity.
• Ensure that all of Amgen’s research procedures are properly measured for performance and that key partners, including management, are informed regularly; work to support the management review system within the Amgen QMS through timely generation of reports and tracking of key actions.
• Support the procedural change process through the communication of metrics designed in collaboration with the Business Process Owner network and leadership across R&D functional areas.
• Collaborate with Business Process Owners and apply risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen’s R&D QMS.
• Lead the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to support periodic review by management to ensure maintenance of QMS health.
• Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).