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
Vendor & Third-Party Management Quality and Compliance Manager - FSP in London employer: PAREXEL
At Parexel, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our team members enjoy competitive benefits, including flexible working arrangements and opportunities for career advancement, all while contributing to impactful global clinical trials in a supportive environment across the UK, Poland, Serbia, and Hungary.
