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.
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