Quality Project Manager

Job not on LinkedIn

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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Oximio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Oximio is a global clinical-trial logistics and supply-chain company that provides tailored cold-chain transport, storage, customs and depot services, sourcing of comparators and ancillary supplies, and patient-focused trial support (direct-to-patient, home nursing, transportation/reimbursement). The firm operates an international network of bonded depots and partners, offers specialized handling for biosamples and cell & gene therapies across temperature regimes down to -196°C, and supports CROs, CDMOs and sponsors with project management, labelling, QP release and regulatory/import services.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.