Astellas Pharma Associate Director, Process Excellence, Medical Affairs in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Associate Director, Process Excellence opportunity in Northbrook, IL.
Purpose & Scope:
- The Associate Process Excellence Director leads process improvement initiatives, process effectiveness, and efficiency checks for Quality Procedures and Operating Models through close collaboration with Process Owner/ Subject Matter Experts (SMEs) for various activities executed by Medical Affairs.
- The incumbent leads cross-functional/regional teams to facilitate development, improvements and implementation of business processes and documentation, to enhance and sustain organizational agility and operational performance.
- The incumbent will collaborate with colleagues from both within and external to the Medical Affairs to ensure the prioritization and timely execution of process improvement projects and deliver measureable outcomes. New or enhanced processes are expected to embed through strategic change management, led by the person assuming this role.
Essential Job Responsibilities:
- Identify, initiate and lead cross-functional process improvement initiatives and thereby improve efficiency and quality within Medical Affairs.
- Serve as Process Excellence expert for Medical Affairs SME's; collaborate with Medical Affairs SME's to identify process/operational gaps or opportunities for process improvement and create enhanced processes to align with overarching Medical Affairs and function specific objectives:
- Serve as Project Manager for Medical Affairs led initiatives
- Create associated project plants, process maps, RACI documents, to support delivery of process improvement project; and provide status reports/presentation (clear and concise communication) in executive format for leaders across multiple functions
- Organize and facilitate cross-functional teams to support continuous process improvement
- When required, draft and manage the associated quality documents (QD), Operating model and/or associated guidance documents, to enable effective implementation of agreed process improvements.
- Drive operational excellence, continuous improvement, sustainability and consistent application of QD standards; sustain the global harmonized QD model.
- Collaborate with regional and global Medical Affairs SMEs to develop and improve global business processes and quality documents that are efficient/practical and appropriately mitigate risks to Medical Affairs.
- Accountable to meet project objectives of global process improvement initiatives, on time, through use of project management principles (including mitigation strategies for at risk projects).
- Lead process effectiveness and efficiency checks, which includes measurement and monitoring of existing processes, development of process improvements to close identified gaps and implementation of desired process changes.
- Participate in non-Medical Affairs process 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 endorsements
- Serves as a change agent; expert to lead the organization through change to achieve organizational adherence to new or modified processes, ensuring business continuity.
- Coordinate with relevant intra-functional stakeholders to develop communication 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.
- Lead multiple cross-functional process improvement projects to completion, including responsibility for managing timelines, priorities and relationships with all stakeholders and measuring adherence and effectiveness of completed initiatives.
- Reports to Senior Director Process & Standards Excellence
- May have 1-2 direct reports (Senior Quality Document Manager)
- Work with cross-functional staff from Development, Pharmacovigilance, Regulatory Affairs, CRQA, OIRE, Legal and Ethics & Compliance
- Matrix leader of Medical Affairs project teams
- Working in virtual teams
- 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.
- Relevant level of experience managing multiple strategic and tactical projects with significant experience in process improvement.
- Proven track record of facilitating process optimization and process change initiatives in a cross-functional setting.
- Experience working cross-functionally and cross-culturally in support of quality management and business processes, especially as they impact and influence multiple departments and levels of management.
- 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.
- 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.
- Understanding of industry best practices in Medical Affairs.
- Demonstrable management experience, including mentoring employees within the department and other functional areas as appropriate.
- Strong knowledge/application of ICH/GCP/ FDA/EMEA regulations and good document management practices
- Relevant process improvement methodology training (e.g. ASQ certification, PMP certification)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Medical Affairs