Executive Director, US Quality Medicine

The Executive Director, (R)
OPU US Quality Medicine leads the US QM organization and drives and continuously improves the vision and concept of the US Medicine Quality Management System and its components. Quality Medicine provides strategic direction for the medicine organization in the US through standards for processes and training, issue management through CAPAs, knowledge management, auditing, and vendor management oversight, in line with the global vision for Quality Medicine.

The Executive Director, US Quality Medicine defines, shapes, and leads the implementation of (R)
OPU US Medicine Quality Management System consistently, based on and in accordance with the global BI Medicine Quality Management System (within and outside of Medicine, as applicable) throughout drug development to maximize patient safety, data integrity, fast and efficient market authorizations, and maintenance of our licenses. This role formulates and is responsible for goals and objectives for the R/OPU QM in accordance with the given global strategy, vision, and goals.

The incumbent contributes and provides insights for global goals as well as lead the (R)
OPU to manage quality and compliance topics to ensure quality of our products and compliance with internal and external regulations. The Executive Director, US Quality Medicine leads continuous development and evolution of the QMS and proactively identifies risks and mitigation measures for all aspects of the QMS including activities for end-to-end inspection management, corrective / preventive actions, supplier oversight as well as oversight of local regulations while being responsible for R/OPU QM resource and budget planning.

This role holds active membership of the (R)
OPU US medical leadership team (MLT) to ensure alignment of Quality topics across functions, consistent implementation of the QMS and regular review of the quality status and risks in the (R)
OPU while being a core member of the Global QM Leadership team and in that role, provides local US insights, contributes to the global strategy and, where applicable, oversees global QM resources located in the US.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

• Accountable for shaping the (R)
  OPU Medicine Quality Management System development, implementation and ongoing maintenance and oversight.
• Leads and Manages the (R)
  OPU QM Team and resource needs.
• Responsible for the organizational structure, appropriate resource, and budget planning.
• Shapes the professional and disciplinary development of assigned employees and ensures that they have relevant skills and competencies to fulfill their role through coaching and talent development empowering them to understand the quality and compliance requirements and implications for their business area.
• For those QM (R)
  OPUs with colleagues in Global Quality Medicine role: ensures alignment with the respective global head to actively support personal development and talent management.
• Responsible for identifying real and potential risks associated with all aspects of the QMS and proposing and implementing solutions to these fundamental and strategically relevant risks.
• Explores & realizes innovative opportunities to enhance the QMS.
• Shapes and provides the framework for Functional Quality (FQAs) Assessments.
• Leads inspections end to end and including timely responses to findings.
• Drives a learning organization by ensuring all aspects of Services and Solutions are embedded into the organization.
• Leads innovation and provides data driven insights…