Head Gl. Medical Quality & Compliance
The Position
At Boehringer Ingelheim, we are committed to driving excellence in global healthcare. As part of this commitment, we are seeking a dedicated and experienced professional to join our team as the Head Global Medical Quality and Compliance. This pivotal role reports directly to the Head Global Quality Excellence and Compliance and plays a crucial part in maintaining and enhancing our global reputation for quality and compliance in the pharmaceutical industry.
The Head Global Medical Quality and Compliance is entrusted with leading a team of Compliance Managers and is responsible for setting and executing our quality plan. This role is at the forefront of ensuring a sustainable and continuous optimization of our Quality Management System, driving quality support and governance for our post-marketing portfolio and cross-functional projects.
Join us in our mission to improve health and well-being at every stage of life. Together, we can make a difference.
Tasks & responsibilities- As the Head Global Medical Quality and Compliance, you will:
- Be responsible for overseeing the performance indicators of the Quality Management System (QMS), such as KPIs and KQIs, and QbD elements within your assigned functions.
- Interface with appropriate levels in the Medicine organization on global quality issues, compliance topics, and improvement initiatives.
- Develop and execute a compliance checks/quality review strategy and an annual quality plan based on risk assessment, in collaboration with the business.
- Ensure issue management following the execution of the quality plan.
- Liaise closely within QM and your assigned Medicine function to gather input on compliance and quality risks, and assign procedural reviews for your assigned functions.
- Lead and manage a team of Compliance Managers who support quality and compliance in Epidemiology, Medical Affairs, Pharmacovigilance and Global Regulatory Affairs functions.
- Collaborate with Functional Quality Responsible roles and manage external consultants to ensure the highest standards of quality and compliance are maintained.
- Communicate site and department goals and expectations to staff and set goals and expectations for staff with their input.
- Ensure conditions necessary for staff performance are met and barriers to performance are removed.
- Provide and ensure a reporting of adequate (quality-) performance indicators which cover all GxP processes, but heavily focused on GCP, and share best practices and lessons learned with Medicine.
- Lead, manage and/or support Regulatory Inspections, facilitating the interactions between inspector and BI.
- Direct, provide feedback and guidance on inspection preparation activities and liaise with respective stakeholders/leaders related to inspection updates, debriefs, Health Authorities responses, etc.
- Doctor degree and/or Master's Degree with several years of experience in the pharmaceutical industry
- Demonstrated success in managing big cross-functional projects as well as leading teams and employees in an international setting, beneficial with a focus on quality and compliance
- Effective leadership/management skills with leadership vision, strong in team building, planning, strategic judgement and decision making
- Excellent skills in conflict management and stakeholder management as well as working on strategic concepts
- Strong strategic thinking, problem-solving, and decision-making skills
- Knowledge in GxP(GCP-preferred), Quality Management System, Quality by Design
- Experience in document management and handling of controlled documents is appreciated
- Fluent in English, any other fluent language skills are beneficial
Ready to contact us?
If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com
Unser Unternehmen
Bei Boehringer Ingelheim entwickeln wir bahnbrechende Therapien, die das Leben von Mensch und Tier verbessern. Als 1885 gegründetes und seitdem im Familienbesitz befindliches Unternehmen nehmen wir eine langfristige Perspektive ein. Mit 52.000 Mitarbeitenden weltweit setzen wir unsere Ziele um und fördern dabei eine vielfältige, gemeinschaftliche und inklusive Unternehmenskultur.Wir sind überzeugt: Mit talentierten und ambitionierten Mitarbeitenden und ihrer Leidenschaft für Innovationen heben wir die Grenzen des Erreichbaren immer wieder auf.
Warum Boehringer Ingelheim?
Bei uns können Sie wachsen, zusammenarbeiten, innovativ sein und Leben verbessern.
Wir bieten Ihnen herausfordernde Tätigkeiten in einem respektvollen und kollegialen globalen Arbeitsumfeld mit einer Vielzahl von auf Innovation ausgerichteten Denkweisen und Methoden. Darüber hinaus sind für uns Qualifizierung und Entwicklung für alle Mitarbeitenden von zentraler Bedeutung, denn Ihr Wachstum ist unser Wachstum.
Boehringer Ingelheim ist ein globaler Arbeitgeber, der sich für Chancengleichheit einsetzt, und ist stolz auf seine vielfältige und inklusive Kultur. Wir begrüßen die Vielfalt von Perspektiven und streben nach einem inklusiven Umfeld, wovon unsere Mitarbeiter*innen, Patienten*innen und Communitys profitieren.
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