Vendor & Third-Party Management Quality & Compliance Manager
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Overview
In this role you will support Global Medical Affairs Vendor & Third-Party Management by driving quality events, investigations, deviations and CAPAs, and assisting with audits. You will contribute to quality risk management, third-party oversight, and due diligence for RCs and non-vendor partners, sustaining compliance and continuous process improvement. You'll collaborate with cross-functional teams to ensure inspection-ready records, evidence, and TPM tooling, shaping a robust quality framework for complex external collaborations. This position offers a meaningful impact on patient outcomes by upholding high-quality external partnerships.
Responsabilità
- Manage Quality Events, Quality Issues, deviations and related investigations with stakeholders
- Act as Deviation Owner and support CAPA lifecycle from definition to closure
- Support internal and external audits and audit readiness and remediation of findings
- Ensure quality records and evidence are complete, traceable, and inspection ready
- Support third-party governance and QRAs across GMA activities (NIS, RWE/RWD, RCs)
- Identify, assess and escalate third-party risks from due diligence and oversight activities
- Coordinate RC/non-vendor due diligence and ensure documentation accuracy in TPM systems
- Maintain and improve TPM due diligence tools (e.g., TPIAT)
- Lead/contribute to design, revision and improvement of GMA V&TPM governance processes
- Provide quality/compliance training to operational teams and stakeholders
- Collaborate with ESP QA, Medical QA, GMA Governance & Risk Management, Procurement, VPG and others for effective oversight
Requisiti fondamentali
- Degree in life science or healthcare-related discipline
- Experience in Vendor & Third-Party Management, QA, Compliance, or related roles in clinical research/Medical Affairs
- Clinical Trial/Medical Affairs experience in pharma or CRO
- Experience with external suppliers, research partners and cross-functional stakeholders
- Strong understanding of clinical/Medical Affairs processes and external services
- Knowledge of regulatory requirements in Clinical Research and drug development (GxP, ICH, FDA, EMA)
- Understanding of Quality Management Systems, GCP/GVP, audit processes, CAPA and risk management
- Knowledge of procurement processes and clinical data systems
- Fluent written and spoken English
- Strong problem-solving, negotiation and conflict resolution skills
- Detail-oriented, accountable, multi-tasking, service-oriented
- Experience in supervising third parties/external suppliers
- problem-solving
- negotiation
- conflict resolution
- GxP
- Quality Management System
- CAPA
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