Quality Leader, France
il y a 4 jours
**Job Description Summary**:
- Lead the Regional Quality Assurance Team
- Ensure that activities comply with French Public Health Code, current GMP/BPF and GDP/BPD legislations, global and local procedures.
- Ensure that global quality assurance strategies take full account of national requirements and are aligned with business needs.
- Ensure that resources are appropriately deployed.
Diriger l'équipe régionale d'Assurance Qualité
- Veiller à ce que les activités soient conformes au Code de la santé publique français, aux législations GMP/BPF et GDP/BPD en vigueur, ainsi qu’aux procédures globales et locales.
- S'assurer que les stratégies globales d'assurance qualité tiennent pleinement compte des exigences nationales et soient alignées avec les besoins de l'entreprise.
- Veiller à une répartition adéquate des ressources.
**Roles and Responsibilities**:
- Leads the France Quality Assurance Team, ensuring that the resource provides high quality, and is seen as a valued strategic partner across the region and global organization and builds effective relationships with regulatory agencies, key decision makers. Member of Professional associations.
- Ensure the organization and management of the quality assurance system for “exploitant” and broker activities concerning the follow-up of the product in compliance with Health code, GMP/BPF, GDP/BPD: technical release, traceability, returns, destruction.
- Determines clear priorities for the QA Team and communicates those to the business so that expectations are appropriately managed.
- Implementation and management of effective resource allocation processes within the QA team and deployment of external support to meet business demands.
- Engenders close and effective working relationships with the other departments, the global QA team (manufacturing sites and sales sites)
- Maintains effective relationships with 3rd Parties e.g. contractors and distributors.
- Ensures that function systems and supporting processes are adequate for effective QA Team operation and that an ongoing process improvement mind set is instilled within the team.
- Performs external and internal audits.
**Responsabilités**:
- Dirige l'équipe Assurance Qualité France, en veillant à ce que les ressources fournissent un travail de haute qualité, soient perçues comme un partenaire stratégique de valeur au niveau régional et mondial, et entretiennent des relations efficaces avec les autorités réglementaires et les décideurs clés. Membre d’associations professionnelles.
- Assure l’organisation et la gestion du système d’assurance qualité pour les activités d’exploitant et de courtier, concernant le suivi du produit en conformité avec le Code de la santé publique, les BPF (GMP) et les BPD (GDP) : libération technique, traçabilité, retours, destructions.
- Définit des priorités claires pour l’équipe AQ et les communique à l’entreprise afin de gérer les attentes de manière appropriée.
- Met en œuvre et gère des processus efficaces d’allocation des ressources au sein de l’équipe AQ, ainsi que le recours à un soutien externe pour répondre aux besoins de l’entreprise.
- Favorise une collaboration étroite et efficace avec les autres départements, l’équipe AQ globale (sites de production et sites commerciaux).
- Maintient des relations efficaces avec les tiers (ex. : sous-traitants, distributeurs).
- S’assure que les systèmes fonctionnels et les processus de soutien sont adaptés au bon fonctionnement de l’équipe AQ, et qu’une culture d’amélioration continue est ancrée dans l’équipe.
- Réalise des audits internes et externes.
**About Us**:
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world
**Par rapport à nous**:
**Inclusion & Diversity statement**:
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Inclusion et Diversité**:
GE HealthCare est un employeur offrant l'égalité des chances où l'inclusion compte. Les décisions relatives à l'emploi sont prises sans tenir compte de l’origine nationale ou ethnique, de la religion, du sexe, de l'orientation sexuelle, de l'identité ou de l'expression de genre, de l'âge, du han
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