Full-Time Client Quality Officer

Client Quality Officer is primarily responsible for implementing and maintaining the quality system and training for assigned client projects, ensuring compliance with global regulations, legislation, PrimeVigilance, and client requirements.

Core responsibilities:

• Direct oversight of all client quality-related activities for the project.
• Close collaboration with Quality Management, Quality Assurance, and Audit Management teams to maintain adherence to PrimeVigilance and Client Quality Management System.
• Close collaboration with Project Manager and Project Team for seamless quality cycle delivery.
• Manage various clients with limited input.
• Ensure timely and complete employee training within client projects.
• Create and maintain a project-specific quality management plan for each assigned project.
• Review weekly and monthly regulatory intelligence reports, assessing impact on projects.
• Ensure alignment and compliance of project procedures with global Pharmacovigilance regulations and guidelines, SOPs, and Joint Operating Guidelines.
• Review and contribute to project procedural documentation, ensuring all activities are supported by implemented SOPs or other documentation.
• Ensure project resources are sufficiently qualified and project team members maintain updated CVs, JDs, and training records.
• Ensure necessary Business Continuity Plans (BCPs) and Disaster Recovery Plans (DRPs) are in place and regularly tested for project activities and systems.
• Review and approve access requests to controlled systems (PACS).
• Regularly review backup, recovery logs, and audit trails for project systems.
• Create and maintain a project-specific training plan and training matrix, collaborating with the Project Manager.
• Review and approve all project-specific training materials created by PrimeVigilance.
• Monitor timely training completion, review competency-based tests, and authorize team members for live work.
• Gather, review, and monitor project metrics and KPIs, identifying and addressing issues or trends.
• Author quality and compliance sections of the project monthly report.
• Conduct a final time quality review of a sample of processed cases each month to maintain quality standards and ensure project inspection readiness.
• Act as the main point of contact for audit activities, compiling pre-audit requests, hosting client audits, coordinating responses to audit findings, and ensuring action completion, contributing to project risk assessments.
• Work with project team members to report deviations appropriately, supporting root cause analysis and categorization.
• Ensure appropriate corrective and preventative actions and effectiveness assessments are proposed.
• Manage project-related deviations and CAPAs for timely completion.

Required skills:

• Life Sciences degree
• Strong previous pharmacovigilance experience, including quality and compliance in a GxP environment.
• Excellent organizational skills, attention to detail, and communication skills
• Leadership qualities (Line Management experience desirable)
• Good IT skills

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