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

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

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 Poland
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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.

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.

• 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.

• 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.

• 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).

• 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…