Vendor & Third-Party Management Quality and Compliance Manager

🕒 vor 29 Tagen

🇪🇸 Spanien – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🚔 Compliance

👻 Geisterscore 15%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Parexel

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1983

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

💰 Venture Round im 1990-01

Consulting • Healthcare • Logistics

Parexel gehört zu den weltweit größten Auftragsforschungsinstituten (CROs) und bietet umfassende Services für den gesamten klinischen Entwicklungsprozess von Phase I bis IV. Das Unternehmen ist spezialisiert auf Portfolio-Management, Studienmanagement, Regulatory-Strategie, Market Access und Lifecycle-Management für Biopharmazeutika. Ziel von Parexel ist es, lebensverändernde Arzneimittel mithilfe seiner klinischen, regulatorischen und therapeutischen Expertise schneller auf den Markt zu bringen. Mit einem globalen Team von über 21. 000 Fachkräften integriert Parexel Patientenperspektiven und innovative Studiendesigns, um Therapien in Indikationsgebieten wie Onkologie, Neurowissenschaften, seltene Erkrankungen und mehr zu entwickeln. Im Fokus stehen patientenzentrierte und effiziente klinische Studien.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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