Vendor & Third-Party Management Quality & Compliance Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7y6y6q

ph3Job Overview /h3 pThe 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. /p h3Job Overview /h3 pThe 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. /p h3Quality Events, CAPAs and Audit Readiness /h3 ul liManage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations in collaboration with relevant stakeholders. /li liAct as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure. /li liSupport internal and external audits, audit readiness activities, and the remediation of audit findings. /li liEnsure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready. /li /ul h3VTPM Quality Risk Management and Compliance /h3 ul liSupport third-party governance and oversight activities from a quality and compliance perspective. /li liSupport 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. /li liIdentify, assess, and elevate potential risks arising from third-party due diligence, qualification, and oversight activities. /li liEnsure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements. /li /ul h3Research Collaboration/non-vendor Due Diligence and Assessment /h3 ul liSupport Research Collaboration (RC) and other selected third-party (non-vendor)



due diligence and assessment activities, as required. /li liEnsure the quality, accuracy, and completeness of due diligence and assessment documentation in TPM systems and tools. /li liCoordinate with internal stakeholders and third parties to obtain information and documentation required for due diligence and assessment activities. /li liSupport the maintenance and continuous improvement of TPM due diligence tools, including TPIAT (Third-Party Impact Assessment Tool). /li /ul h3Process Improvement, Training and Stakeholder Collaboration /h3 ul liLead and/or contribute as a subject matter expert to the design, revision, implementation, and continuous improvement of GMA VTPM quality, compliance, governance processes, standards, procedures, and guidance documents. /li liSupport the development, revision, and implementation of relevant procedures, standards, and guidance documents. /li liProvide VTPM quality and compliance expertise, guidance, and training to operational teams and stakeholders. /li liCollaborate 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. /li /ul h3Requirements /h3 ul liDegree in a life science or healthcare-related discipline /li liPrevious experience in Vendor Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities. /li liClinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required. /li liExperience 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. /li liStrong understanding of clinical and Medical Affairs processes, study management activities, and associated external services. /li liGood knowledge of the regulatory requirements in Clinical Research and drug development:



/li liIn-depth knowledge of the international pharmaceutical product development process /li liExperience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities. /li liA broad understanding of main Health Authorities standards, including FDA and EMA requirements, as well as ICH regulations and guidelines. /li liStrong understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles. /li liUnderstanding of procurement processes and Knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA and new technologies...) /li liExperience and ability to manage/supervise third parties and external suppliers. /li liGood understanding of clinical data systems/platforms and overall integration of clinical data system and processes /li liLanguage proficiency: fluent written and spoken English knowledge /li liStrong problem-solving, negotiation and conflict resolution skills. /li liDiligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, good with numbers /li /ul pIQVIA 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 /p pIQVIA 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. /p pThe 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 tempo parziale). 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. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7y6y6q