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.

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

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

• Ensure timely and comprehensive employee training within client projects.

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

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

• Ensure compliance of project procedures with global pharmacovigilance regulations, guidelines, SOPs, and Joint Operating Guidelines.

• Review and contribute to procedural documentation related to projects.

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

• Establish and test Business Continuity Plans and Disaster Recovery Plans.

• Review and approve access requests for controlled systems.

• Review backup and recovery logs, as well as audit trails for project systems.

• Evaluate training materials, oversee training completion, and authorize team members for live work.

• Collect and monitor project metrics and KPIs, addressing any issues or trends observed.

• Author quality and compliance sections for monthly project reports.

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

• Maintain readiness for project inspections.

• Serve as the primary contact for project audit activities, coordinating audit requests, responses, and actions.

• Contribute to the assessments of project risks.

• Support the reporting of deviations, root cause analysis, and categorization processes.

• Ensure that corrective and preventive actions as well as effectiveness assessments are proposed.

• Manage 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.

• Capability to manage a variety of clients with minimal input.

• Ability to ensure adherence to global regulations, legislation, PrimeVigilance, and client requirements.

🏝️ Benefits

• Flexible work arrangements / remote work options.

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

• Collaborative team environment.

• Opportunities for professional development.

• Global reach with purpose-driven work.

• Passionate and collaborative team of experts.

• Diverse and inclusive workplace.

• Employee referral program.