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Responsable Global de la Transformation Digitale de la Qualité H/F Ceva Santé Animale
- Libourne - 33
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
- Exp. 1 à 7 ans
- Exp. + 7 ans
Les missions du poste
Global Digital Quality Lead
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our Together, Beyond Animal Health vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our Diversity, Equity and Inclusion policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Your
missions :
Mission:
The Global Digital Quality Lead acts as the primary advocate for quality in digital transformation, providing strategic direction and full lifecycle oversight of digital quality solutions. This role ensures alignment with business and regulatory goals, representing quality priorities across all global sites and functions. As Business Process Owner (BPO) for quality, the lead drives harmonization, standardization, and continuous improvement through digital enablement. Collaborating within the OpEx, Digital & AI organization, the role ensures adoption, measurable impact, and integration of quality into digital decisions, aligned with enterprise-wide process standardization, operational excellence, and data science initiatives.
Responsibilities:
Strategic Leadership: Provide strategic vision and leadership for digital quality solutions, ensuring alignment with business objectives and quality standards.
Quality Advocacy: Act as the central voice for quality in digital transformation, embedding quality requirements into digital strategies across global operations.
Lifecycle Management: Oversee the full lifecycle of digital quality systems, from development and implementation to scaling, optimization, and continuous improvement.
Stakeholder Engagement: Collaborate with cross-functional teams-including operations, manufacturing, regulatory, finance, IT, and external partners-to ensure seamless integration and adoption of digital quality tools.
Process Harmonization and Standardization: Lead global quality process harmonization through digital enablement, serving as BPO and aligning with enterprise-wide excellence and data initiatives.
Performance Monitoring and Optimization: Track, analyze, and report on digital quality system performance, adoption, and value realization, providing insights for ongoing improvement.
Innovation and Continuous Improvement: Identify and champion opportunities for innovation and process advancement in digital quality management.
Compliance and Regulatory Alignment: Ensure all digital quality systems meet or exceed pharmaceutical industry standards and global regulatory requirements.
Budget and Resource Management: Manage budgets and resources for digital quality initiatives, ensuring timely delivery and maximum value.
Value Maximization and Adoption: Drive organization-wide adoption of digital quality systems to enhance business performance, operational efficiency, and quality outcomes.
Computerized System Validation (CSV): Ensure digital quality systems are validated in accordance with internal SOPs (e.g., QCORPH-QSOP-00012) and global regulatory standards (e.g., EU GMP Annex 11, 21 CFR Part 11, GAMP5), supporting audit readiness and compliance.
Your
profile :
Bachelor's degree in a relevant field required; advanced degree preferred.
Demonstrated ability to lead innovation and continuous improvement in digital environments.
Proven experience managing budgets and resources to deliver high-impact digital projects.
Track record of leading large-scale adoption of digital solutions to improve performance and efficiency.
Experience working in global, cross-functional teams across diverse cultures.
Minimum one year of experience at a manufacturing or quality site to ensure operational depth.
Relevant industry certifications are considered an asset.
Experience applying CSV frameworks in pharmaceutical or similarly regulated industries.
Familiarity with global regulatory expectations for computerized systems (e.g., EU GMP Annex 11, 21 CFR Part 11, GAMP5).
Hands-on experience with JD Edwards EnterpriseOne or equivalent ERP systems (e.g., Oracle Cloud ERP, SAP) in a regulated manufacturing or quality environment.
Proven ability to define, optimize, and validate quality processes within ERP platforms, including URS development, batch status management, and defect tracking.
Experience leading ERP-related digital transformation initiatives, preferably in pharmaceutical or life sciences industries.
Diplôme d'ingénieur ou universitaire dans un domaine pertinent pour le rôle
Capacité démontrée à piloter l'innovation et l'amélioration continue dans des environnements digitaux.
Expérience avérée dans la gestion de budgets et de ressources pour livrer des projets digitaux à fort impact.
Historique de réussite dans l'adoption à grande échelle de solutions digitales visant à améliorer la performance et l'efficacité.
Expérience de travail au sein d'équipes mondiales et transverses, dans des environnements multiculturels.
Minimum d'un an d'expérience sur un site de production ou de qualité, afin d'assurer une compréhension opérationnelle approfondie.
Les certifications industrielles pertinentes sont considérées comme un atout.
Expérience dans l'application des cadres de validation des systèmes informatisés (CSV) dans l'industrie pharmaceutique ou dans des secteurs réglementés similaires.
Bonne connaissance des attentes réglementaires mondiales concernant les systèmes informatisés (ex. : EU GMP Annexe 11, 21 CFR Part 11, GAMP5).
Expérience pratique avec JD Edwards EnterpriseOne ou des systèmes ERP équivalents (ex. : Oracle Cloud ERP, SAP) dans un environnement de production ou de qualité réglementé.
Capacité avérée à définir, optimiser et valider les processus qualité dans des plateformes ERP, y compris le développement d'URS, la gestion du statut des lots et le suivi des défauts.
Expérience dans la conduite d'initiatives de transformation digitale liées aux ERP, de préférence dans les industries pharmaceutiques ou des sciences de la vie.
- Accord Télétravail
- Offre de formation innovante
- Crèche d’entreprise
- Groupes de travail participatifs aux enjeux RSE
- Espaces de pause collaboratifs
- Restaurant d’entreprise
- Intéressement ou participation
- Comité d'entreprise
Ceva Santé Animale en images
Pas de salaire renseigné
Publiée le 05/11/2025 - Réf : req6684
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Responsable Global de la Transformation Digitale de la Qualité H/F
- Libourne - 33
- CDI
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