Senior Quality Specialist, Client Quality Management

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

📋 Description

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

• Ensure that projects comply with global regulations, legislation, PrimeVigilance standards, and client specifications.

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

• Collaborate with teams including Quality Management, Quality Assurance, Audit Management, Project Manager, and Project Team.

• Manage several clients simultaneously and deliver results with minimal supervision.

• Ensure that employee training is timely and comprehensive.

• Develop and maintain quality management plans, training plans, and training matrices specific to each project.

• Analyze regulatory intelligence reports and evaluate their impact on projects.

• Confirm that project procedures comply with pharmacovigilance regulations, guidelines, SOPs, and Joint Operating Guidelines.

• Review and provide contributions to procedural documentation for projects.

• Verify that project resources are appropriately qualified, and ensure that employee CVs, job descriptions, and training records are up-to-date.

• Ensure that Business Continuity Plans and Disaster Recovery Plans are established and regularly tested.

• Review and authorize access requests for controlled project systems.

• Examine backup, recovery logs, and audit trails for systems related to projects.

• Review and approve training materials specific to each project.

• Monitor the completion of training, assess competency tests, and authorize team members for live work.

• Track project metrics and KPIs, identify trends, and facilitate prompt issue resolution.

• Write quality and compliance sections for monthly project reports.

• Conduct final-time quality reviews on samples of processed cases.

• Maintain readiness for project inspections.

• Act as the primary contact for audit activities related to projects.

• Organize audit preparation, client audits, responses to audits, and proposed actions.

• Contribute to Quality Assurance risk assessments.

• Assist with deviation reporting, root cause analysis, and categorization.

• Ensure that corrective and preventive actions and effectiveness assessments are recommended.

• Manage project deviations and CAPAs to ensure prompt resolution.

⛳️ Requirements

• Degree in Life Sciences.

• Extensive 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

• Flexible remote work options.

• A collaborative and supportive work atmosphere.

• Opportunities for growth and development.

• Exposure to a global team and international work.