The Position Are you able to manage the nearly impossible? And do you see yourself as a quality and compliance expert? Then you are exactly right with us! In your role as Functional Quality Responsible (FQR), Global Function Vendor Manager (GFVM), and Function Risk Management Representative, you will support Translational Medicine & Clinical Pharmacology (TMCP) to deliver the Global Medicine and Functional Quality strategy, foster a quality culture and promote continuous improvement. You will provide Good Clinical Practice (GCP) consulting and support TMCP employees with thorough root cause analysis and the determination of appropriate CAPAs. Interested? Then we look forward to your application and to seeing how competently you can respond to international regulatory inspections! Tasks & responsibilities Quality & Compliance Leadership In your new role, you will act as key contact for Global Quality Medicine (Business Partners and Compliance Managers) and serve as a member of relevant working groups. Global Quality Processes Furthermore, you will define quality and compliance goals, drive implementation and ensure oversight of quality related processes (focus GCP) and projects within TMCP under consideration of Quality Medicine (QM) Strategy as well as departmental needs. Regulatory Compliance You will support TMCP in ensuring GCP compliance and inspection readiness, including in clinical trials with patients and healthy volunteers, while providing proactive GCP guidance and advice to project, study and functional teams. Additionally, you will ensure awareness and adherence to international GxP and Pharmacovigilance, regulatory requirements, In Vitro Diagnostic Regulation (IVDR), Medical Device Regulation (MDR) and industry best practices. Quality and Compliance Oversight and process improvement The support and supervision for Quality and Compliance topics within TMCP as well as the monitoring of in-process quality control checks and the identification of Corrective Actions and Preventive Actions (CAPAs) will be part of your responsibilities. You will also support and collaborate with Global Process Owners (GPOs) and functional quality employees to identify and implement process improvements. Supplier Oversight Management You will work with TMCP functions, Global Sourcing, Legal, and Quality representatives to manage supplier qualifications and ensure overall quality and compliance assurance, while developing innovative supplier qualification strategies. Inspection and Audit Management Moreover, you will develop and support inspection readiness activities and act as business point of contact for auditing and inspection readiness as well as conduct; also, you will provide direct inspections and audits support (training, preparation and management). You will ensure follow-ups on quality-related findings from audits and inspections. Handling of non-compliances (NCs) / CAPA management In addition, you assume process ownership, define strategies and oversight for NCs You will also support in initial assessment of potential NCs, root cause analysis, creation of CAPA plans, identification of CAPA Leads / act as CAPA Lead and database entries, all in collaboration with QM. Requirements Master's degree in a scientific field, such as Biology, Biochemistry, or Chemistrywith longstanding extensive professional experience in Good Clinical Practice (GCP) related environment,PhD desirable Extensive experience with GxP quality management processes and systems. In-depth knowledge of local and global GCP regulations with robust experience in interpreting GCP guidelines for the pharmaceutical industry Significant experience in inspection and audit readiness, preparation and management and in (GCP) non-compliances and CAPA management Knowledge and experience in drug development, clinical development and GCP for labs Applied knowledge of IVDR and MDR as well as experience in companion diagnostics (CDx) development is a plus Creative and critical thinker with the ability to identify areas for improvement and independently develop tailored solutions, coupled with strong leadership and assertiveness 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 via mail: hr.de@boehringer-ingelheim.com Recruitment process: Step 1: Step 1: Online application - The job posting is presumably online until July 2, 2025. Step 2: Virtual meeting mid of July Step 3: On-site interviews end of July Discover our Biberach site: xplorebiberach.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. Sie möchten mehr erfahren? Dann lesen Sie hier weiter https://www.boehringer-ingelheim.com