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 adherence 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 direction.

• Guarantee timely and thorough employee training within client projects.

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

• Analyze regulatory intelligence reports and evaluate their effects on assigned projects.

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

• Review and contribute to the documentation of project procedures.

• Verify that project resources are qualified and keep personnel records updated.

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

• Review and authorize controlled-system access requests.

• Evaluate backup, recovery logs, and audit trails.

• Review and approve training materials specific to the project.

• Monitor completion of training, competency assessments, and authorization for live work.

• Track project metrics and KPIs, addressing any issues or trends that arise.

• Write quality and compliance sections for monthly project reports.

• Conduct final quality reviews on selected processed case samples.

• Maintain readiness for inspections.

• Serve as the primary contact for project audit activities and coordinate audit responses and corrective measures.

• Contribute to project risk evaluations.

• Assist in deviation reporting, root cause analysis, categorization, corrective actions, preventive actions, and assessments of effectiveness.

• Manage project deviations and CAPAs ensuring timely completion.

⛳️ Requirements

• Degree in Life Sciences.

• Extensive prior experience in pharmacovigilance, including quality and compliance within a GxP environment.

• Strong organizational abilities.

• Keen attention to detail.

• Exceptional communication skills.

• Proficient IT skills.

🏝️ Benefits

• Option for remote work.

• A collaborative and supportive team culture.

• Flexible work environment.

• Opportunities for growth.

• A workplace focused on belonging.

• Exposure to global pharmacovigilance, clinical research, and quality consulting teams.