Vendor & Third-Party Management Quality and Compliance Manager – FSP

Overview

As part of Parexel’s GMA V&TPM quality and compliance team, you will manage quality events, deviations, and audits, collaborating with stakeholders to drive CAPAs and audit readiness. You will support third-party governance, QRAs, and due diligence, ensuring documentation and systems stay inspection-ready. You’ll help design and improve governance processes, provide training, and coordinate with cross-functional teams to uphold regulatory standards. This role offers meaningful impact across clinical development and partnerships.

Responsibilities

• Manage Quality Events (QEs), Quality Issues (QIs), deviations and investigations with stakeholders
• Act as Deviation Owner and support CAPA definition, tracking, and closure
• Support internal and external audits and remediation of audit findings
• Ensure quality records and evidence are complete, traceable, and inspection-ready
• Support third-party governance and Quality Risk Assessments (QRAs) for NIS, RWE/RWD, RCs and partnerships
• Conduct third-party due diligence and assessment activities; maintain documentation in TPM systems
• Lead or contribute to design and improvement of GMA V&TPM quality, compliance, governance processes and guidance documents
• Provide QA/gov training to operational teams and stakeholders; collaborate with multiple functions to oversee third-party activities
• Coordinate information gathering with internal and external parties for due diligence and assessment
• Maintain and improve TPM due diligence tools, including TPIAT (Third-Party Impact & Assessment Tool)

Key requirements

• Degree in life science or healthcare-related discipline
• Experience in Vendor & Third-Party Management, QA, Compliance, or related role in clinical research or Medical Affairs
• Clinical Trial/Medical Affairs experience in pharmaceutical company or CRO
• Experience working with external suppliers and cross-functional stakeholders in pharma/CRO environments
• Strong understanding of clinical and Medical Affairs processes and study management
• Knowledge of GxP requirements, quality management systems, and regulatory requirements from Health Authorities
• Familiarity with FDA, EMA, ICH guidelines and CAPA/risk management concepts
• Understanding of procurement processes and external supplier landscape (CROs, labs, eCOA, etc.)
• Proficiency in clinical data systems and integration of clinical data processes
• Fluent in written and spoken English
• Strong problem-solving, negotiation and conflict resolution skills
• Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented

• Problem-solving
• Negotiation
• Conflict resolution
• GxP knowledge
• Quality Management System (QMS)
• Audit and CAPA management

…