The Head of Quality Medicine defines, shapes and leads the Medicine Quality Management System (QMS) in the country consistently, based on and in accordance with the integral Boehringer Ingelheim Medicine QMS throughout drug development to maximize patient safety, data integrity, fast and efficient market authorizations and maintenance of our licenses.
**Tasks and responsibilities**:
- Formulate and drive goals and objectives for the country in Quality Medicine in accordance with the given local strategy, vision, and goals, as well as contribute and provide insights for global goals.
- Lead the country to manage quality and compliance topics to ensure quality of our products and healthcare solutions, especially with the increasingly entrance of digital technologies in the new healthcare ecosystem and in compliance with internal and external regulations. Responsible for Quality and Compliance technical expertise in strategic and cross-organizational specialist topics/projects.
- Lead and manage the Quality Medicine team in the country, and resources needed. Responsible for the organizational structure, appropriate resource, and budget planning.
- Lead continuous development and evolution of the QMS and identify risks and mitigation measures for all aspects in the QMS, including activities for end-to-end inspection management, corrective / preventive actions, supplier oversight as well as oversight of local regulations.
- Lead innovation in terms of Quality Medicine and provide data driven insights to the organization.
- Engage in relevant industry associations / work groups to bring in industry best practices in house and contribute to the definition of future industry best practices.
- Active membership of the Medical Management Leadership team to ensure alignment of Quality topics across functions, consistent implementation of the QMS and regular view of the quality status and risks in the country.
**Requirements**:
- University degree (master’s or comparable degree) in scientific discipline (pharmacy, biology, chemistry, among others).
- Minimum five years’ experience in similar position, leading teams.
- Expertise in ICH GcP, GvP, and all applicable external regulations in terms of Quality Medicine.
- Significant direct experience with / participation in regulatory authority inspections and interacting with Regulatory authorities.
- Demonstrated experience with design, implementation and/or management of Quality Management Systems.
- In depth knowledge of Quality by Design (QbD) approaches
- Deep understanding of the overall drug development process to advise on adopting of innovative approaches across clinical development.
- Digital approach of the medicine function. Equipped for quality in the new healthcare ecosystem.
- Knowledge of specific technologies, e.g.: data collection technologies and the associated (potential) regulations.
- Skills: Communication & presentation, Influencing & negotiating, leadership, data analytics, critical thinking, risk management, project management
- English fluent in written, reading, speaking
- Availability to travel regionally and internationally as needed, and ideally able to relocate in the future.
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