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 www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid 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
Qualifications:
Required
Bachelor’s Degree or equivalent in science or health-related field required or an advanced degree in business administration
Minimum 10 years in the pharmaceutical industry and/or management consulting group focused on Quality and/or Process Management.
Experience working cross-functionally and cross-culturally in support of continuous improvement, quality management, Operating model simplification, process optimization and change initiatives; especially as they impact and influence multiple departments and levels of management
Relevant level of experience managing multiple strategic and tactical projects with significant experience in process improvement
Strong and effective problem solver with the ability to both recognize and anticipate problems
Demonstrated ability to translate solutions into sustainable action plans at a global level that are effectively disseminated and implemented through stakeholder collaboration
Demonstrated competency in developing Quality Documents
Experience in leading or managing audit or monitoring activities or nonconformance management
Demonstrated leadership in a matrix organization; ability to influence and motivate team members.
Strong English communication skills: verbal, written and presentation required
Demonstrated ability to prioritize multiple projects effectively
Demonstrated ability to work effectively, independently and work across a global organization and different regions/cultures
Knowledge/application of ICH/GCP/GVP/ FDA/EMEA regulations and good document management practices
Preferred
Understanding of industry best practices in Medical Affairs
Demonstrable management experience, including mentoring employees within the department and other functional areas as appropriate
Relevant process improvement/ Quality certification (e.g., ASQ, Lean, Six Sigma etc.)
Relevant Project Management certification (e.g., PRINCE2, PMI etc.)
Relevant Change Management certification (e.g., PROSCI etc.)
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
*LI-JB1
Category Operational Excellence
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans