Lead EU-QPPV Office

The Position

We are looking for a Lead EU-QPPV Office in our Regional PV / EU-QPPV Team. In his pivotal role you will be responsible for providing insights in the effectiveness of Boehringer's Pharmacovigilance system, in line with regulatory requirements. Further, you will define the quality framework for PSPV, fostering connections with internal and external stakeholders to promote quality aspects and achieve regulatory requirements of our PV system. You will be a key player in coordinating Pharmacovigilance inspections and internal as well as external audits. The Lead EU-QPPV Office will also coordinate and develop a global PSPV Training Strategy to ensure the completion of mandatory trainings for maintaining an effective and efficient PV system.

If you are a team player with a structured quality thinking mindset who is passionate about working in a dynamic environment to constantly improve PSPV quality, we would love to hear from you. Join us in shaping the future of Patient Safety & Pharmacovigilance at Boehringer Ingelheim.

Tasks & responsibilities

• In your new role, you will lead the respective EU-QPPV Office team, providing guidance and support to ensure smooth operations for assigned tasks.
• Guaranteeing adherence to the BI Quality Management System (QMS) Framework will be a key part of your role.
• You will have an overview of the Pharmacovigilance System Performance,
• Coordinating Pharmacovigilance inspections as well as internal and external audits will fall under your responsibilities.
• You will coordinate and develop a global PSPV Training Strategy, ensuring the completion of compliance relevant trainings as well as identified ad-hoc trainings.
• Overseeing the handling of PV Quality Events and CAPAs, incl. ensuring centralized PV Non-Compliance reporting in line with our processes and adequate tools and timelines will be part of your duties
• Designing best practices for PV Non-Compliance handling will be part of your role, while additionally representing the PV needs and gathering feedback to optimize the Non-Compliance processes.
• Responsible for PV system description maintenance in line with respective regulatory requirements
• Act as the Global Functional Vendor Manager (GFVM) for PSPV and oversee interaction with Quality Medicine Supplier Management (for PV and PV related suppliers)
• Lastly, you will use your networking skills to connect with other functions for appropriate support, such as Quality Medicine, Regulatory Affairs, etc.

Requirements

• Master's degree in Life Sciences and several years of experience (on local or global level) in PV Auditing and Inspections, PV Compliance, Corrective and Preventive Actions Management and Supplier Management
• Profound knowledge of PV regulations and PV Compliance, including different components and interfaces of PV Systems
• Experience in planning and conducting PV inspections and audits with the capability to identify process improvement opportunities
• Know-How in analyzing data and information related to the PV quality system, defining the right compliance indicators and drawing appropriate conclusions
• Capability to prioritize related actions and following up on their effective implementation
• Team leader with strong networking, communication and interpersonal skills paired with the ability to influence and motivate others
• Analytical and strategic thinking to understand processes and draw conclusions

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

Recruitment process:
Step 1: Online application - application deadline is mid of December, 2024
Step 2: Virtual meeting in December
Step 3: On-site interviews beginning of January

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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