Associate Director, Quality Excellence Medical Affairs

Associate Director, Quality Excellence Medical Affairs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

• The Associate Director Process and Quality Excellence leads cross-functional/regional teams to facilitate continuous improvement initiatives for Medical Affairs including Operating Model design; facilitates development, improvements, implementation and monitoring of business processes and documentation
• Collaborates with colleagues from both within and external to the Medical Affairs to ensure the prioritization, execution and successful adoption of process improvement and quality deliverables
• Oversees and executes Quality related processes (e.g., Non-conformance, Document Management, Audits, and Inspections etc.)

Essential Job Responsibilities:

• Identify, initiate, and lead cross-functional continuous improvement initiatives (focusing on improving efficiency, effectiveness and quality) within Medical Affairs
• Serve as a Process, Standards and Quality expert for Medical Affairs SME’s
  • Collaborate with Medical Affairs SME’s to identify process/operational gaps or opportunities for process improvement; create enhanced processes to align with overarching Medical Affairs and function specific objectives
  • When required, draft and manage the associated quality documents and/or associated guidance documents, to enable effective implementation of agreed improvements (ensure quality documents that are efficient/practical and embed quality principles to optimize Medical Affairs performance and appropriately mitigate risks, where needed)
  • Lead process effectiveness and efficiency checks, which includes measurement and monitoring of existing processes, development of quality improvements to close identified gaps and mitigate business risk
• Function as Project Manager for Medical Affairs-led improvement initiatives
  • Accountable to meet project objectives of global process improvement initiatives, on time, through use of project management principles (including risk mitigation strategies).
  • Create associated project deliverables (including plans, process maps, RACI documents, status reports etc.)
  • Presents (clear and concise communication) in executive format for leaders across multiple functions
• Serve as a change agent for Medical Affairs led improvements
  • Lead the organization through change to achieve organizational adherence to new or modified processes.
  • Coordinate with relevant intra-functional stakeholders to develop communication and training plans for new/enhanced processes and working practices
• Work closely with appropriate training group(s) (e.g., Medical Affairs Training; E&C Training; 3rd party provider) to create training material and advise on training audience and methods.
• Participate in non-Medical Affairs process and quality improvement projects that impact Medical Affairs (e.g., led/owned by PV, Development, RA, Ethics & Compliance, Legal) in close alignment with Medical Affairs SMEs; ensure outcomes meet Medical Affairs leadership’s expectations
• Works closely with Head of MA Quality and Risk Management on the oversight and management of:
  • MA Document Change Control
  • MA Nonconformance /CAPAs
  • Audits /inspections with potential MA impact
  • MA Risk Management

Quantitative Dimensions:

• Accountable for the implementation of Process improvement and Change Management strategies in support of the overall MA global organization of over 900 individuals. Provides consultation, advice, and subject matter expertise
• Provide monitoring and coordination (i.e., periodic review) across MA for over 200 quality documents, including related oversight and tracking of internal audits and external audit/inspections
• Lead 4-6 cross-functional process and quality improvement projects to completion, including responsibility to manage timelines, priorities and relationships with all stakeholders and measure adherence and effectiveness of completed initiatives

Organizational Context:

• Reports to Senior Director Process & Standards Excellence
• Works in virtual team setting both interdepartmentally and with cross-functional staff (including, but not limited to, Development, Pharmacovigilance, Regulatory Affairs, Quality, Legal and Ethics & Compliance etc.)
• Matrix leader of Medical Affairs project teams
• Working in virtual teams