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

Parexel International; España; Híbrido; EUR 70.000 - 95.000; Jornada completa

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 offers you the security of a long-term position and many opportunities for career progression.

We are currently recruiting talented and passionate people to join our FSP teams in Spain.

The Vendor & Third-Party Management Quality and Compliance Manager position 100% remotely gives you the opportunity to join a team with a wide range of experience and expertise.

Position Purpose:

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.

Major Accountabilities:

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

We will offer you

• Premium salary.
• Attractive benefits.
• Medical care plan: Health, Dental & Vision.
• Life Assurance.
• Excellent work environment.
• Culture of teamwork and collaboration.
• People who motivate and face challenges together.
• Innovative technology.
• Excellent training.