Vendor and Third-Party Management Quality and Compliance Manager

Job not on LinkedIn

🔥 1 minute ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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, 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 NIS, RWE/RWD, Research Collaborations, and partnerships • Identify, assess, and escalate risks from third-party due diligence, qualification, and oversight • Ensure compliance with SOPs, business guidance, quality standards, and regulatory requirements • Support Research Collaboration and selected non-vendor third-party due diligence and assessment activities • Coordinate with 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 quality and compliance expertise, guidance, and training to operational teams and stakeholders • Collaborate with Quality Assurance, Medical QA, 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 • 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, risk management, and regulatory requirements from main Health Authorities • Broad understanding of FDA and EMA standards, 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 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 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

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training • Long-term position and opportunities for career progression