Vendor & Third-Party Management Quality and Compliance Manager

🕒 il y a 29 jours

🇪🇸 Espagne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🚔 Conformité

👻 Score fantôme 15%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Parexel

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1983

💼 Conseil

🏥 Santé

📦 Logistique

💰 Venture Round en 1990-01

Consulting • Healthcare • Logistics

Parexel est l'une des plus grandes organisations de recherche clinique (CRO) au monde, fournissant des services complets pour le processus de développement clinique de la Phase I à IV. L'entreprise se spécialise dans la gestion de portefeuille, la gestion des essais cliniques, la stratégie réglementaire, l'accès au marché et la gestion du cycle de vie des produits biopharmaceutiques. Parexel vise à accélérer la mise sur le marché de médicaments qui changent la vie en tirant parti de son expertise clinique, réglementaire et thérapeutique. Avec une équipe mondiale de plus de 21 000 professionnels, Parexel s'efforce d'intégrer les perspectives des patients et des conceptions d'essais innovantes pour développer des traitements dans des domaines thérapeutiques tels que l'oncologie, les neurosciences, les maladies rares et plus encore. Elle se concentre sur la fourniture d'essais cliniques centrés sur le patient et efficaces.

Description

• Provide Quality Assurance support for Global Medical Affairs Vendor & Third-Party Management • Manage quality events, quality issues, deviations, investigations, and Corrective and Preventive Actions (CAPAs) • Act as Deviation Owner when appropriate • Support CAPA definition, implementation, tracking, effectiveness assessment, and closure • Support internal and external audits, audit readiness activities, and remediation of audit findings • Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready • Support third-party governance and oversight from a quality and compliance perspective • Contribute to third-party Quality Risk Assessments and follow up on identified risks and mitigation actions • Identify, assess, and escalate risks from third-party due diligence, qualification, and oversight • Ensure compliance with SOPs, business guidance documents, quality standards, and regulatory requirements • Support Research Collaboration and selected non-vendor third-party due diligence and assessment activities • Coordinate with internal stakeholders and third parties to obtain due diligence information and documentation • Maintain and improve TPM due diligence tools, including TPIAT • Lead or contribute as a subject matter expert to the design, revision, implementation, and improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance • Provide V&TPM quality and compliance expertise, guidance, and training • Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders

🎯 Exigences

• Degree in a life science or healthcare-related discipline • Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities • Clinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required • Experience working with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment • Experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management • Strong understanding of clinical and Medical Affairs processes, study management activities, and associated external services • Good knowledge of regulatory requirements in Clinical Research and drug development • In-depth knowledge of the international pharmaceutical product development process • Experience with GxP requirements, quality management systems including risk management, and regulatory requirements from main Health Authorities • Broad understanding of main Health Authorities standards, including FDA and EMA requirements, as well as ICH regulations and guidelines • Strong understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles • Understanding of procurement processes and clinical external supplier landscape, including CROs, Central Labs, specialty services, eCOA, and new technologies • Experience and ability to manage/supervise third parties and external suppliers • Good understanding of clinical data systems/platforms and overall integration of clinical data systems and processes • Fluent written and spoken English • Strong problem-solving, negotiation, and conflict resolution skills • Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, and good with numbers

🏖️ Avantages

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training