Senior Quality Specialist, Client Quality Management

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Execute and uphold the quality system and training for designated client projects.

• Ensure projects adhere to global regulations, legislation, PrimeVigilance standards, and client specifications.

• Supervise all quality-related activities for assigned client projects.

• Collaborate with Quality Management, Quality Assurance, Audit Management, Project Managers, and project teams.

• Handle multiple clients and deliver results with minimal supervision.

• Ensure timely and comprehensive training for employees.

• Develop and maintain project-specific quality management and training plans.

• Analyze regulatory intelligence and evaluate impacts on projects.

• Review and contribute to procedural documentation and ensure compliance with SOPs.

• Confirm that project resources are qualified and personnel records are up-to-date.

• Maintain and test Business Continuity and Disaster Recovery Plans.

• Review and authorize controlled-system access requests.

• Examine backup, recovery logs, and audit trails.

• Track training completion, competency assessments, and team approvals.

• Collect and monitor project metrics and KPIs.

• Draft quality and compliance sections for monthly reports.

• Conduct final quality reviews of processed cases.

• Ensure readiness for inspections.

• Organize audits, manage audit responses, and propose corrective actions.

• Assist in quality risk assessments.

• Support deviation reporting and root-cause analysis.

• Ensure corrective and preventive actions, along with effectiveness evaluations, are proposed.

• Oversee project deviations and CAPAs to ensure timely completion.

⛳️ Requirements

• Degree in Life Sciences.

• Extensive prior experience in pharmacovigilance.

• Experience in quality and compliance within a GxP environment.

• Strong organizational skills.

• Keen attention to detail.

• Exceptional communication skills.

• Proficient IT skills.

🏝️ Benefits

• Option for remote work.

• Culture of kindness, flexibility, growth, and belonging.

• Collaborative team environment.

• Opportunities for professional development.

• Global impact and meaningful work focused on patient protection.