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Astellas Pharma Director Medical Affairs, Quality & Risk Management 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 a Director, Medical Affairs (MA) Quality & Risk Management opportunity.

Purpose & Scope:

The Director of Medical Affairs (MA), Quality & Risk Management sets the strategic vision to advance excellence of execution for MA activities, with the highest level of quality. The incumbent works closely with MA leaders and stakeholders to ensure compliance with evolving regulatory requirements in the Pharmaceutical industry and to embed practices in MA operating procedures that foster a culture of commitment to quality. The Director of MA Quality & Risk Management will establish and maintain a 1-3-year strategic roadmap for MA Quality & Compliance and leads the quality matrix to ensure implementation of the annual quality strategic goals and objectives for MA.

Essential Job Responsibilities:

  • Collaborates with MA leadership to annually review MA's mission and objectives, with regards to risk mitigation and quality management; is accountable for the successful execution of the risk management plan.

  • Leads MA cross-regional quality management matrix to drive compliance and quality throughout the MA organization.

  • Serves as MA primary point of contact for Astellas' internal audit/monitoring functions (i.e. Clinical and Regulatory Quality Assurance (CRQA), Internal Audit; Ethics & Compliance (E&C); and is accountable to coordinate MA contributions to the annual strategic plans that are generated by these groups, particularly with regards to activities undertaken by these functions, that have an impact on Medical Affairs.

  • Partners with CRQA, E&C and Internal Audit to identify areas of business risk and collaborates with MA stakeholders to prioritize high risks and develop mitigation strategies to reduce risk across MA and with other functional area partners. Provide insight into the QA audit plan to ensure MA meets compliance standards, including management, support and participation in the oversight of MA audit activities and preparedness.

  • Collaborates closely with the Process & Standards Excellence Leader and other stakeholders (e.g. process owners) to ensure that quality is embedded in MA operating procedures and monitors for compliance to MA quality principles.

  • Establish and maintain standards for pre, during and post audit/inspection activities.

  • Upgrade MA proficiency for external regulatory inspection and internal audit readiness, including providing mentoring/training to enhance understanding of the associated standards & processes and how to perform CAPA root cause analysis, CAPA impact assessment and appropriate corrective and preventative actions.

  • Accountable for full oversight of all MA audit/inspection findings and other quality related issues; serve as MA primary point of contact for MA audits & inspections.

  • Provides audit and inspection leadership through leading strategic meetings with MA leadership, performing interview preparation training, coordination audit support, including Clinical Regulatory Quality Assurance (CRQA) inspection support.

  • Accountable for Corrective Actions/Preventative Actions (CAPA) oversight within MA

  • Establishes and maintains the standards for appropriate CAPA investigation (e.g. increase root cause analysis proficiency for the function), including ensuring that inspection/audit findings are effectively addressed and CAPAs are closed out within target timelines.

  • Contribute to audit/inspection responses; provide CAPA expert support to CAPA issue owners (e.g. process owners/SMEs/tactic owner), to enable effective root cause and (global) impact analysis

  • Ensure effectiveness checks are performed for applicable CAPAs

  • Performs continuous monitoring of compliance and develops and delivers metrics associated with risks or trends in findings from audit/monitoring activities, identifying areas of potential gaps/risks/issues for MA improvement/enhancements, working closely with MA stakeholders and non-MA stakeholders (Process & Standards Excellence, CRQA, Internal Audit, E&C, Legal), to address areas requiring improvement.

  • Responsible for global coordination and management of MA deviations (planned and unplanned), provide guidance to the MA function on the development, implementation and evidence collection for deviations.

  • Ensure oversight on progress, evidence collection, negotiation timeline extensions with relevant MA, non-MA and external (e.g. License Partners) stakeholders, as required.

Quantitative Dimensions:

  • Accountable for the implementation of MA Quality & Risk Management strategies to support the overall MA global organization of approximately 900 individuals.

  • Provides consultation, advice and subject matter expertise regarding quality requirements and addresses compliance questions when they arise.

  • Provide oversight and tracking of internal MA audits (planned & completed), per the Quality Audit schedule and additional external audits/inspections, CAPA management and oversight, and quality/business document maintenance.

  • Provide monitoring across MA quality procedures or non-MA owned procedures that impact MA activities.

Organizational Context:

  • Reports to Ex Dir Standards, Ops Optimization, Quality & Training

  • Member of M&D CAPA Oversight Board

  • Oversight matrix management of up to 5 additional MA colleagues, with future potential management of approximately 1 person

  • Collaborates with function Operational Excellence leads and closely partners with Process & Standards Excellence Head for embedding of quality into various MA led activities (e.g. Medical Information; Project Management; TA Leads) and other functions (PV, Development, etc.)

Qualifications:

Required

  • Minimum 10 years of experience within a BA or BA, OR minimum of 7 years of experience with a MS, OR minimum of 3 years of experience with a MD, PhD, Pharm D in the pharmaceutical industry or related fields.

  • Minimum of 5 years of project management and process and/ or quality management experience facilitating cross-functional teams in the pharmaceutical industry or related fields, preferably in a matrixed, multicultural, global setting requiring facilitation, negotiation, problem-solving and conflict resolution skills.

  • Experience with global responsibilities for audits/inspections and safety process improvement projects.

  • 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.

  • Successful track record in building effective business relationships, effectively collaborating, and building rapport with functional team members, and partners within and outside of MA (e.g. M&D, Legal, Ethics and Compliance etc.)

  • Strong interpersonal skills and multi-cultural/intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.

  • Ability to facilitate a change process and influence without authority as part of a matrix organization.

  • Excellent collaboration and communication skills to facilitate team discussions and drive optimal team performance

  • Experience in leading and managing audit or monitoring activities.

  • Demonstrated ability to manage multiple projects and competing priorities.

  • Excellent communication and presentation skills in English (written and spoken) and able to lead meetings, present orally and interact with external bodies.

  • Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization.

  • Ability to meet timelines that may require a flexible work schedule.

  • Domestic and/or international travel of 5-10% may be required.

Preferred

  • Demonstrated high level of competence with MS Office applications and ability to learn new systems and software rapidly.

*LI-CH1

Category Medical Affairs

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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