Vendor & Third-Party Management Quality & Compliance Manager

IQVIA; Roma; In loco; EUR 52.000 - 96.000; Tempo pieno

Descrizione del lavoro

IQVIA in Italy seeks a Quality Assurance professional to support Global Medical Affairs Vendor & Third-Party Management, focusing on quality events, CAPAs, deviations, audits, and inspection readiness. You will also contribute to third-party risk assessments and due diligence, ensuring compliant records and effective governance.

Collaborating with ESP QA, Medical QA, GMA Governance & Risk Management, and VPG, you will drive TPM tool improvements and continuous process enhancement.

Competenze

• Degree in life science or healthcare discipline.
• Experience in Vendor & Third-Party Management and QA/compliance.
• Clinical research/Medical Affairs in pharma or CRO.
• Strong knowledge of GxP, ICH, FDA/EMA regulations.
• Fluent English, written and spoken.

Mansioni

• Manage Quality Events (QEs), Quality Issues (QIs), deviations, and CAPAs with stakeholders.
• Support internal and external audits, audit readiness activities and remediation of findings.
• Ensure quality records, supporting documentation, and evidence are complete, traceable, and inspection ready.
• Contribute to Quality Risk Assessments (QRAs) and third-party risk assessments.
• Support RC due diligence and non-vendor third-party assessment activities.
• Lead or contribute to TPM process design, revision, and continuous improvement.

Conoscenze

Quality Assurance

Vendor mgmt

CAPA management

GxP compliance

Audit readiness

Regulatory knowledge

Quality systems

English fluency

Formazione

Life science degree

Strumenti

TPM systems

Descrizione del lavoro

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.

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 elevate 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 https://jobs.iqvia.com

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.