Full-Time Client Quality Officer

Client Quality Officer is primarily responsible for the implementation and maintenance of the quality system and training for assigned client projects.

Ensuring project compliance with global regulations, legislation, PrimeVigilance, and client requirements.

Core Responsibilities:

• Direct oversight of all client quality-related activities.
• Collaboration with Quality Management, Quality Assurance, and Audit Management teams to ensure adherence to PrimeVigilance's and client's quality management systems.
• Close collaboration with Project Managers and Project Teams to ensure seamless delivery of the quality cycle.
• Management of multiple clients with limited input.
• Ensuring timely and complete employee training within client projects.
• Creation and maintenance of project-specific quality management plans.
• Review of weekly and monthly regulatory intelligence reports and assessment of impact on designated projects.
• Alignment and compliance of project procedures with global Pharmacovigilance regulations and guidelines (SOPs and Joint Operating Guidelines).
• Review and contribution to project-related procedural documentation ensuring SOP or other documentation support.
• Ensuring project resources are qualified and project team members maintain updated CVs, JDs, and training records.
• Implementation and regular testing of Business Continuity Plans (BCPs) and Disaster Recovery Plans (DRPs) for project activities and systems.
• Review and approval of access requests to controlled project systems (PACS).
• Regular review of backup, recovery logs, and audit trails for project-related systems.
• Creation and maintenance of project-specific training plans and matrices, in conjunction with the Project Manager.
• Review and approval of project-specific training materials.
• Monitoring of training completion, review of competency-based tests, and sign-off of team members for live work.
• Gathering, reviewing, and monitoring project metrics and KPIs; identifying and addressing issues/trends.
• Authorship of quality and compliance sections of project monthly reports.
• Final time quality review of a sample of fully processed cases each month to maintain quality standards and ensure inspection readiness.
• Main point of contact for audit activities, compiling pre-audit requests, hosting client audits, coordinating responses to audit findings, and ensuring completion of proposed actions; working closely with the Audit Management team.
• Support with root cause analysis and categorization of deviations.
• Ensuring appropriate corrective and preventative actions and effectiveness assessments are proposed.
• Management of project-related deviations and CAPAs for timely completion.

Qualifications:

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

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