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Quality Project Manager

Stelle nicht auf LinkedIn

🕒 vor 1 Monat

🇬🇧 Vereinigtes Königreich – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👷‍♀️ Projektmanager

🗣️🇺🇸🇬🇧 Englisch erforderlich

Woher diese Stelle stammt

Veröffentlicht auf der Karriereseite von Oximio, nicht über eine Jobbörse

Von Remote Rocketship zum ersten Mal gesehen vor 1 Monat

Noch offen auf der Website von Oximio. Geprüft vor 6 Stunden.

Logo of Oximio

Oximio

201 - 500 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Oximio ist ein globales Unternehmen für Logistik und Supply-Chain-Management in klinischen Studien, das maßgeschneiderte Dienstleistungen für den Transport in der Kühlkette, Lagerung, Zoll- und Depotservices, Beschaffung von Vergleichssubstanzen und zusätzlichen Materialien sowie patientenorientierte Studienunterstützung (Direkt-zum-Patienten, häusliche Pflege, Transport/Erstattung) anbietet. Das Unternehmen betreibt ein internationales Netzwerk von Bruttolagerstätten und Partnern, bietet spezialisierte Handhabung für Bioproben sowie Zell- und Gentherapien in Temperaturbereichen bis zu -196°C und unterstützt CROs, CDMOs und Sponsoren mit Projektmanagement, Kennzeichnung, QP-Freigabe sowie regulatorischen/Import-Dienstleistungen.

Beschreibung

• Lead and coordinate the quality workstream of major strategic projects, including M&A and business integration activities. • Conduct quality and regulatory gap assessments to identify differences between Oximio and new or existing business operations. • Develop and coordinate quality integration plans, identifying processes, systems, documentation and controls that need to be implemented, changed or harmonised. • Perform and coordinate risk assessments and ensure that quality and regulatory risks are identified, documented and appropriately addressed. • Assess the impact of strategic projects on GxP, GDP, ISO and other applicable quality and regulatory requirements. • Work with senior stakeholders and cross-functional teams to define project objectives, priorities, actions and timelines from a quality perspective. • Collaborate with Quality, Operations, IT, Legal and other business functions to ensure successful project delivery. • Work directly with stakeholders from acquired companies, partners and other external organisations during integration and transformation activities. • Support the assessment and implementation of new processes, systems and operational models as part of major projects. • Monitor quality-related project activities, identify risks or gaps and ensure that agreed actions are followed through to completion. • Provide clear updates and recommendations to the Chief Quality Officer and senior leadership team. • Take ownership of quality-related projects that require dedicated project management and coordination. • Provide additional quality support when required, including temporary support for operational Quality activities across Oximio.

🎯 Anforderungen

• Bachelor's degree in Quality, Life Sciences, Pharmaceutical Sciences, or a related field. • Strong professional background in Quality and/or Regulatory Affairs within a highly regulated industry. • Project management experience, ideally managing complex, cross-functional or strategic projects. • Good working knowledge of GxP and GDP requirements, with knowledge of relevant ISO standards. • Experience with risk assessments, gap analysis, process evaluation and quality improvement activities. • Experience working across multiple functions and coordinating stakeholders to deliver complex projects. • Experience in M&A, business integration, implementation or transformation projects is highly desirable; direct experience leading an acquisition is not required. • Excellent communication and stakeholder management skills, including confidence working with senior leadership and external stakeholders. • Good working knowledge of English.

🏖️ Vorteile

• Join a growing international company supporting clinical research worldwide. • Take ownership of high-impact projects directly connected to Oximio's growth and strategic development. • Gain exposure to M&A, business integration, transformation and strategic project management. • Opportunity to shape a newly established role and develop the quality project management function at Oximio. • Professional development opportunities in an international and purpose-driven environment.

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