Vendor Management Quality and Compliance Manager - FSP

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Oversee Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations in collaboration with pertinent stakeholders.

• Serve as Deviation Owner when necessary, and assist in the definition, execution, monitoring, effectiveness evaluation, and closure of Corrective and Preventive Actions (CAPA).

• Aid in internal and external audits, prepare for audit readiness activities, and address audit findings.

• Ensure that quality records, supporting documents, and evidence are complete, precise, traceable, and ready for inspection.

• Assist with third-party governance and oversight activities from a quality and compliance standpoint.

• Contribute to third-party Quality Risk Assessments (QRAs) for GMA activities, including non-interventional studies, real-world evidence/data initiatives, Research Collaborations, and partnerships.

• Follow up on identified risks and their mitigation strategies.

• Identify, evaluate, and escalate risks arising from third-party due diligence, qualification, and oversight tasks.

• Ensure adherence to relevant Standard Operating Procedures (SOPs), business guidance documents, quality standards, and regulatory obligations.

• Support Research Collaboration and selected third-party non-vendor due diligence and evaluation tasks.

• Confirm that due diligence and assessment documentation is accurate and comprehensive in TPM systems and tools.

• Coordinate with internal teams and third parties to gather necessary due diligence information and documentation.

• Aid in the maintenance and continuous enhancement of TPM due diligence tools, including TPIAT.

• Lead or participate as a subject matter expert in the design, revision, implementation, and refinement of V&TPM quality, compliance, governance processes, standards, procedures, and guidance.

• Provide quality and compliance expertise, guidance, and training to operational teams and stakeholders.

• Collaborate with Quality Assurance, Medical QA, Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other relevant parties.

⛳️ Requirements

• Bachelor’s degree in a life science or healthcare-related field.

• Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities.

• Required clinical trial/medical affairs experience in a pharmaceutical organization or a Contract Research Organization (CRO).

• Experience in collaborating with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment.

• Familiarity with clinical/medical affairs processes and activities, along with a strong understanding of study management.

• Comprehensive knowledge of clinical and Medical Affairs processes, study management activities, and related external services.

• Good grasp of regulatory requirements in Clinical Research and drug development.

• Extensive knowledge of the international pharmaceutical product development process.

• Experience with GxP requirements, quality management systems, including risk management, and regulatory requirements from major Health Authorities.

• Solid understanding of FDA and EMA requirements, as well as ICH regulations and guidelines.

• Strong comprehension of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles.

• Understanding of procurement processes and the landscape of clinical external suppliers (CROs, Central Labs, specialty services, eCOA, and new technologies).

• Demonstrated experience managing or supervising third parties and external suppliers.

• Good understanding of clinical data systems/platforms and the overall integration of clinical data systems and processes.

• Proficient in written and spoken English.

• Strong problem-solving, negotiation, and conflict resolution abilities.

• Diligent, detail-oriented, accurate, accountable, able to manage multiple tasks, service-oriented, and proficient with numbers.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive and dynamic work environment.

• Work with a talented and diverse team.