供应商及第三方管理质量与合规经理
Vendor & Third-Party Management Quality & Compliance Manager
职位名称：供应商及第三方管理质量与合规经理
工作地点：英国伯克郡雷丁
工作地点类型：远程
工作合同类型：全职
职位级别：
职位概述
该职位为全球医学事务供应商及第三方管理提供质量保证支持，主要通过管理质量事件、质量问题、偏差和纠正与预防措施（CAPA），以及审计支持和审计准备。该角色还支持研究合作（RC）尽职调查和部分非供应商第三方评估活动，并参与第三方质量风险管理、合规性和持续流程改进。
质量事件、CAPA和审计准备
• 与相关利益相关者协作，管理质量事件（QEs）、质量问题（QIs）、偏差及相关调查。
• 根据需要担任偏差负责人，支持CAPA的定义、实施、跟踪、效果评估和关闭。
• 支持内部和外部审计、审计准备活动以及审计发现的整改。
• 确保质量记录、支持性文件和证据完整、准确、可追溯且可供检查。
供应商及第三方管理质量风险管理与合规
• 从质量和合规的角度支持第三方治理和监督活动。
• 支持并参与第三方质量风险评估（QRAs），并确保评估完成、记录并保存用于相关GMA活动，包括非干预性研究（NIS）、真实世界证据和真实世界数据（RWE/RWD）活动、研究合作（RCs）和合作伙伴关系。跟进识别的风险及相应的缓解措施。
• 识别、评估并上报来自第三方尽职调查、资质审核和监督活动的潜在风险。
• 确保符合适用的标准操作规程（SOP）、业务指导文件、质量标准和监管要求。
研究合作/非供应商尽职调查与评估
• 根据需要支持研究合作（RC）和其他选定的第三方（非供应商）尽职调查与评估活动。
• 确保TPM系统和工具中的尽职调查和评估文档的质量、准确性和完整性。
• 与内部利益相关者和第三方协调，获取尽职调查所需的信息和文档。
查看英文原文
Job Title: Vendor & Third-Party Management Quality & Compliance Manager
Job Location: Reading, Berkshire, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
The position provides Quality Assurance support for Global Medical Affairs Vendor & Third-Party Management, primarily through the management of quality events, quality issues, deviations, and Corrective and Preventive Actions (CAPAs), as well as audit support and audit readiness. The role also supports Research Collaboration (RC) due diligence and selected non-vendor third-party assessment activities and contributes to third-party quality risk management, compliance, and continuous process improvement.
Quality Events, CAPAs and Audit Readiness
• Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations in collaboration with relevant stakeholders.
• Act as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure.
• Support internal and external audits, audit readiness activities, and the remediation of audit findings.
• Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready.
V&TPM Quality Risk Management and Compliance
• Support third-party governance and oversight activities from a quality and compliance perspective.
• Support and contribute to third-party Quality Risk Assessments (QRAs) and ensure assessments are completed, documented, and maintained for relevant GMA activities, including non-interventional studies (NIS), real-world evidence and real-world data (RWE/RWD) activities, Research Collaborations (RCs), and partnerships. Follow up on identified risks and associated mitigation actions, as appropriate.
• Identify, assess, and escalate potential risks arising from third-party due diligence, qualification, and oversight activities.
• Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements.
Research Collaboration/non-vendor Due Diligence and Assessment
• Support Research Collaboration (RC) and other selected third-party (non-vendor) due diligence and assessment activities, as required.
• Ensure the quality, accuracy, and completeness of due diligence and assessment documentation in TPM systems and tools.
• Coordinate with internal stakeholders and third parties to obtain information and documentation required for due diligence and assessment activities.
• Support the maintenance and continuous improvement of TPM due diligence tools, including TPIAT (Third-Party Impact & Assessment Tool).
Process Improvement, Training and Stakeholder Collaboration
• Lead and/or contribute as a subject matter expert to the design, revision, implementation, and continuous improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance documents.
• Support the development, revision, and implementation of relevant procedures, standards, and guidance documents.
• Provide V&TPM quality and compliance expertise, guidance, and training to operational teams and stakeholders.
• Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance (VPG), and other relevant stakeholders to ensure effective oversight of third-party activities.
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. Emphasis on business, 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 the regulatory requirements in Clinical Research and drug development:
- In-depth knowledge of the international pharmaceutical product development process
- Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
- A 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 Knowledge of clinical external suppliers landscape (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 system and processes
- Language proficiency: fluent written and spoken English knowledge
- Strong problem-solving, negotiation and conflict resolution skills.
- Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, good with numbers
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is 225.500,00 zł - 418.600,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas