Vendor & Third-Party Management Quality and Compliance Manager

Job not on LinkedIn

🔥 2 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage Quality Events, Quality Issues, deviations, and related investigations with relevant stakeholders • Act as Deviation Owner and 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 for GMA activities, including non-interventional studies, real-world evidence/data activities, Research Collaborations, and partnerships • 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 continuously 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

🎯 Requirements

• 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 • 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 FDA and EMA requirements, and 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 suppliers 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 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, good with numbers