Remote Vendor & Third-Party Quality & Compliance Manager

Parexel International

España

Híbrido

EUR 70.000 - 95.000

Jornada completa

Hace 11 días
Generador de candidaturas

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Ventajas ofrecidas por este puesto de trabajo

Premium salary
Benefits package
Healthcare plan
Life assurance
Excellent work environment

Descripción de la vacante

Parexel FSP in Spain is actively seeking a Vendor & Third-Party Management Quality and Compliance Manager to join our 100% remote team. The role focuses on QA support for Global Medical Affairs V&TPM, managing quality events, CAPAs, audits, and ongoing risk management.

You will collaborate with cross-functional stakeholders, drive continuous process improvement, and ensure compliance with GxP and global regulatory standards in a CRO/pharma setting.

Formación

  • 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 CRO is required.
  • Experience working with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO.
  • Strong understanding of clinical and Medical Affairs processes and study management.
  • Good knowledge of regulatory requirements in Clinical Research and drug development, including FDA/EMA/ICh guidelines.
  • Experience with GxP, quality management systems, and CAPA/risk management.
  • Understanding of procurement processes and external suppliers landscape (CROs, labs, etc.).
  • Ability to manage/supervise third parties and external suppliers.
  • Fluent written and spoken English.

Responsabilidades

  • Manage Quality Events, CAPAs, deviations, and audit readiness with stakeholders.
  • Act as Deviation Owner and support CAPA definition, tracking and closure.
  • Support internal and external audits and remediation of findings.
  • Ensure quality records and evidence are complete and inspection ready.
  • Support third-party governance, QRAs and risk assessments.
  • Identify and elevate risks from due diligence and oversight activities.
  • Coordinate information for due diligence and assessment activities for RCs and non-vendor partners.
  • Lead and contribute to design and improvement of GMA V&TPM quality processes.
  • Provide QA guidance and training to operational teams and stakeholders.
  • Collaborate with ESP QA, Medical QA, GMA Governance & Risk Management, and VPG for oversight.

Conocimientos

English fluency
Quality management
Vendor & Third-Party management
Clinical/Medical affairs knowledge
GxP / regulatory knowledge
Problem-solving
Negotiation skills
Conflict resolution
Stakeholder management
Attention to detail

Educación

Degree in life science or healthcare-related discipline

Descripción del empleo

Parexel FSP in Spain is actively seeking a Vendor & Third-Party Management Quality and Compliance Manager to join our 100% remote team. The role focuses on QA support for Global Medical Affairs V&TPM, managing quality events, CAPAs, audits, and ongoing risk management.

You will collaborate with cross-functional stakeholders, drive continuous process improvement, and ensure compliance with GxP and global regulatory standards in a CRO/pharma setting.

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