Job Title

*Description** 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. **Duties & Responsibilities** + 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 to the organization. + Responsible for the R/OPU Quality Management Review. + Leads the identification and proactive communication of relevant QMS topics from the (R)OPU via the appropriate communication/escalation channels, to ensure global oversight of quality topics and continuously improve the global quality management system for BI Medicine. + As a Quality and Compliance Subject matter expert, contributes to the definition of the strategic goals of other organizational/functional units and the QM Global goals. + Leads and fosters a Quality Culture to meet current business needs and support future innovation and regulatory changes. + Engages in relevant industry associations / work groups to bring in industry best practices in house and contribute to the definition of future industry best practices. + Responsible for technical expertise outside the company as required. + Responsible for Quality and Compliance technical expertise in strategic and cross-organizational specialist topics/projects. + Fosters cross functional and divisional quality discussions to identify synergies and optimize the global BI quality management system; this includes interactions with other (R)OPU quality and compliance organizations (e.g., Healthcare compliance, Commercial Quality, etc.). + Drives integration of QMS across US divisions (e.g., development, E&C, IS) towards an overall integration for BIPI. Leads BI Medicine to meet regulatory requirements by: + Leading and ensuring that quality and compliance standards are understood and proactively embedded within the (R)OPU. + Driving consistent and harmonized implementation and continuous improvement of the QMS within Medicine. + Shaping a feedback culture on all aspects of the QMS including Non compliances, CAPAs, inspection findings and audits to address risks and compliance gaps. + Providing data driven insights. **Requirements** + University degree (Master's or comparable degree) in a scientific discipline e.g. Pharmacology or other life science - or relevant experience + **Quality Management and Compliance Expertise** : In-depth understanding of QM processes, QMS sub-elements, Quality by Design (QbD) approaches, and relevant external regulations to provide appropriate advice and ensure compliance. + **Strategic and Technological Insight** : Knowledge of BI organization and strategy, R&D processes, digital suppliers, and new technologies to contribute to strategic goals, advise on innovative approaches, and mitigate risks related to data integrity and regulatory adherence. + **Communication, Leadership, and Influence** : Effective communication, influencing, negotiating, and leadership skills to engage with individuals across BI, articulate options, delegate tasks, and maintain oversight. + **Analytical and Project Management Skills** : Proficiency in data analytics, critical thinking, presentation design, risk management, and project management to support decision-making, identify recommendations, and manage cross-functional projects. + **QM Behaviours** : able to adopt and incorporate QM expected Behaviours into how the role delivers their accountabilities including: being pragmatic, solution oriented, collaborative, customer focused and proactive + Ability to travel regionally and internationally as needed **Compensation** This position offers a base salary typically between $200,000 and $316,000. Please reach out to Talent Acquisition or your HR Business Partner for more information. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.