Full-Time Client Quality Officer

Client Quality Officer is responsible for implementing and maintaining quality systems and training for assigned client projects. Ensures compliance with global regulations, PrimeVigilance, and client requirements.

Core Responsibilities:

• Oversees all client quality-related activities for the project.
• Collaborates with Quality Management, Quality Assurance, and Audit Management teams to maintain compliance with PrimeVigilance's and the client's quality management systems.
• Works closely with project managers and teams to ensure seamless delivery of the quality cycle.
• Manages multiple clients, delivering work with limited input.
• Ensures timely and complete employee training within client projects.
• Creates and maintains a project-specific quality management plan for each project.
• Reviews weekly and monthly regulatory intelligence reports, assessing impact on designated projects.
• Ensures project procedures align with global pharmacovigilance regulations and guidelines (SOPs, Joint Operating Guidelines).
• Reviews and contributes to project procedural documentation to support activities with implemented SOPs or other documentation.
• Ensures project resources are qualified, and project team members maintain updated CVs, job descriptions, and training records.
• Establishes and regularly tests Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) for project activities and systems.
• Reviews and approves access requests to controlled systems (PACS).
• Regularly reviews backup, recovery logs, and audit trails for project systems.
• Creates and maintains project-specific training plans and matrices, collaborating with the project manager.
• Reviews and approves project-specific training materials created by PrimeVigilance.
• Monitors training completion, reviews competency-based tests, and approves team members for live work.
• Gathers, reviews, and monitors project metrics and KPIs, addressing any issues or trends promptly.
• Authors quality and compliance sections of the project monthly report.
• Conducts final time quality reviews on a sample of processed cases each month to maintain quality standards and ensure inspection readiness.
• Serves as the primary contact for audit-related activities, collaborating with the Audit Management team to compile pre-audit requests, host client audits, coordinate responses to audit findings, and ensure completion of proposed actions. Contributes to project risk assessments.
• Works with team members to report deviations appropriately, providing support with root cause analysis and categorization.
• Ensures appropriate corrective and preventative actions and effectiveness assessments are proposed.
• Manages project deviations and CAPAs for timely completion.

Qualifications:

• Life Sciences degree
• Strong 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

Benefits:

• Training and career development
• Emphasis on personal and professional growth
• Supportive work environment
• International collaboration opportunities

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