Senior Director, Enterprise Quality Governance - International Distribution Services

Sr. Director Of Enterprise Quality Governance : International Distribution Services

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The Sr. Director Of Enterprise Quality Governance : International Distribution Services, under the general direction of the VP, Enterprise Quality is responsible to the SVP of Legal and Regulatory Team under Legal and Consulting Services and the Cencora Board to support the quality strategy and standardization as a strategic advisor. This includes providing leadership, collaboration, management, support, assessment, and communication of quality, practice standards and regulatory requirements for Cencora (COR) business units operating in the healthcare and life sciences industry which have a focus on pharmaceutical distribution and manufacturing activities and 3rd party logistics in the Europe and Asia regions. This position acts cross-functionally with internal Cencora Assurance groups, Cencora business Quality Units, functional departments, and external resources on quality and regulatory-related issues. The incumbent is accountable for ensuring Business Unit (BU) adherence to relevant regulatory quality requirements and company Standard Quality Operating Procedures and Policy. The incumbent may act in a quality leadership, license or support role for any Cencora business unit, during times of transition or integration as directed by the VP or SVP in accordance with their residency and / or registration.

Primary Duties And Responsibilities :

• Support the VP with the implementation of Enterprise Quality (EQ) strategic plans to support organizational quality goals and provide direct guidance to business quality leaders operating in the pharmacy services arena.
• Liaison and Support for EQ Advisors : for support on quality metrics, follow-up, outlier management and tracking improvement activities.
• Collaboration : Work with quality business leaders and GQC to prioritize strategy for the development, standardization, harmonization, and continuous improvement of the global regulatory and quality governance program.
• Assist in the Management of the Cencora regulatory intelligence repository for pharmacy services and care to ensure, monitoring, updates, legal review, and communication occur for appropriate business operations.
• Provide oversight for assigned regions and BUs with guidance for the implementation of operating procedures intended to comply with applicable regulatory requirements, practice standards and corporate quality policy.
• Assure that operational business quality systems have implemented the seven elements of quality and can report performance KPIs to the Global Quality Council and executive leadership.
• Support, articulate, and gain alignment across the organization for the COR regulatory / quality strategy and lead the creation of related procedures and policies.
• Foster a culture of continuous regulatory and health authority inspection / accreditation preparedness and serve as an escalation point for quality issues, inspection and accreditation support.
• Participate in planning activities for operating budgets and forecasts; manage team and personal expenses to ensure operational expense goals are met.
• Participate in the development and maintenance of policies, programs, and systems to support the strategic direction of the department and assigned service lines.
• Monitor and communicate all new, modified, and / or existing state, country / regional / federal and / or local regulations to the legal regulatory team to ensure appropriate changes are communicated to have BUs amend their procedures, processes, and methods to comply with new changes.
• Participate, assist and provide guidance in any external quality related inspection, audit, and / or investigation from any healthcare regulatory or accreditation authority, if requested as well as for Client, Customer or for Quality related certification.
• Communicate and Support comprehensive quality governance policies and procedures to guide BU operations in executing private label distribution and market access holder procedures in compliance with stated requirements and best practice.
• Team Leadership : Oversee corporate task teams related to new business strategies. Manage direct reports, including hiring, performance management, development and training.
• Collaborate with outside organizations and participate in external committees to address significant industry issues.
• Assist in preparing EQ monthly and quarterly summaries for executive management and the Compliance and Risk Committee of the Board of Directors as requested by the VP or SVP.
• Perform related duties as assigned, including supporting other EQ Governance Advisors, participation on committees, teams and projects as directed or requested by the VP or SVP.

Experience And Educational Requirements :

Minimum Skills, Knowledge, and Ability Requirements :