Astellas Pharma Associate Director, Regional Process & Quality, 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 Regional Process & Quality opportunity in Northbrook, IL.
Purpose & Scope:
- The Associate Regional Process & Quality Director for Medical Affairs (MA), through close collaboration with Process Owner/SMEs, leads regional and global process improvement initiatives and process effectiveness and efficiency checks for Quality Procedures and Operating Models that drive various activities executed by MA.
- The incumbent leads cross-functional/regional teams to facilitate development of or improvements to, and associated 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 MA, to ensure the prioritization and timely execution of process improvement projects and deliver measurable outcomes. New or enhanced processes are expected to be embedded through strategic change management, led by the person assuming this role.
- The Associate regional Process & Quality Director facilitates and coordinates internal and external audits within the applicable region. The incumbent operates as a member of the MA Quality & Risk Management Matrix team to maintain an environment of audit/inspection readiness and reinforce practices consistence with a quality driven organization.
Essential Job Responsibilities:
- Regional representative for Process Excellence Matrix team.
- Identify, initiate and lead regional process improvement initiatives; lead global initiatives, as agreed within the Process Excellence Matrix team. Through these initiatives, actively engage in the ongoing effort to improve efficiency and quality across MA.
- Collaborate with MA SMEs to identify process/operational gaps or opportunities for process improvement and create enhanced processes to align with overarching MA and function specific objectives.
- Collaborate with regional and global MA SMEs to develop and improve global business processes and quality documents that are efficient/practical and appropriately mitigate risks to MA.
- Serve as project manager for MA led initiatives.
- Create associated project plans, pross maps, RACI documents, etc. to support delivery of process improvement projects; and provide status reports/presentations (clear and concise communication) in Executive format, for leaders across multiple functions.
- When required, draft and manage the associated Quality Documents (QD), and/or associated guidance documents, to enable effective implementation of agreed process improvements.
- Drive operational excellence, continuous improvement, sustainability and consistent application of QD Utilizes advanced understanding and awareness of internal and external environmental changes and opportunities to ensure ongoing innovative enhancements and operational standards; sustain the global harmonized QD model.
- Accountable to meet project objectives of process improvement initiatives led by the Associate Regional Process & Quality Director, on time, through use of project management principles (including mitigation strategies for at risk projects)
- Perform impact assessment of proposed changes and lead embedding of process changes across MA, in a way that is sustainable.
- 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-MA process improvement projects that impact MA (e.g. led/owned by PV, Development, RA, Ethics & Compliance, Legal), in close alignment with relevant MA SME(s); ensure outcomes meet MA business needs and MA leadership's endorsement.
- Serves as 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. MA Training; E&C Training; 3rd party provider) to create training material and advise on training audience and methods for initiatives being led by the incumbent or those that have an impact on the region to which the incumbent is aligned.
- Monitor and influence industry trends and best practices for identified areas for improvement and propose solutions.
- Propose, drive and implement changes to regional quality documents; perform continuous monitoring of regional MA owned QDs, ensuring the implementation of a continuous quality document-improvement process for MA, and maintain compliance with periodic review standards of quality documents, including accurate revisions and versioning.
- Author, edit and gain approval for MA-owned Quality Documents;
- Ensure Medical Operations Function(s) strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.
Quality & Risk Management:
- Regional representative for Quality & Risk Management Matrix team.
- Serve as first point of contact for region, for internal and external audits and inspections.
- Pro-actively inform MA region Leadership of audit planning activities.
- Support MA Quality & Risk Management group on implementation of inspection and audit readiness and process changes, in order to successfully ensure audit/inspection readiness.
- Provide hands on support for audit/inspection activities for MA within the region, by facilitating and coordinating communication, responses etc.
- Support MA Quality & Risk Management group CAPA investigations and CAPA actions, as applicable, for MA within the region.
- Lead multiple cross-functional regional and global process improvement projects to completion, including responsibility for managing timelines, priorities and relationships with all stakeholders
- Measure adherence and effectiveness of completed initiatives.
- Coordinate and facilitate all regional internal and external audits
- Reporting line to Executive Director, Medical Operations
- Works with cross-functional staff from Development, Pharmacovigilance, Regulatory Affairs, CRQA, OIRE, Legal and Ethics & Compliance
- Matrix leader of MA project teams
- Regional representative for MA Process Excellence Matrix team and for MA Quality and Risk Management Matrix team
- 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