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 along with training for designated client projects.

• Provide direct supervision of quality-related activities for clients.

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

• Ensure timely and thorough employee training within client projects.

• Develop and uphold project-specific quality management plans, training plans, and training matrices.

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

• Ensure that project procedures adhere to 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 keep CVs, job descriptions, and training records up to date.

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

• Review and authorize access requests to controlled project systems.

• Review backup and recovery logs, along with audit trails for systems related to projects.

• Review and approve training materials specific to the project.

• Monitor training completion, evaluate competency tests, and sign off team members for live work.

• Collect and track project metrics and KPIs, identifying and addressing any issues or trends.

• Author the quality and compliance sections of monthly project reports.

• Conduct final-time quality reviews on sampled processed cases to ensure projects remain inspection-ready.

• Act as the primary contact for project audit activities, host client audits, coordinate responses to findings, and ensure completion of actions.

• Contribute to project risk assessments.

• Support deviation reporting, root cause analysis, and categorization.

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

• Manage project deviations and CAPAs to ensure timely completion.

⛳️ Requirements

• Degree in Life Sciences.

• Strong prior experience in pharmacovigilance.

• Quality and compliance experience within a GxP environment.

• Excellent organizational skills.

• Strong attention to detail.

• Exceptional communication skills.

• Good IT skills.

• Ability to manage multiple clients with minimal input.

• Capability to ensure compliance with global regulations, legislation, PrimeVigilance, and client requirements.

🏝️ Benefits

• Flexible work arrangements / remote work.

• Opportunities for growth.

• A collaborative and supportive work environment.

• Exposure to a global team and international projects.

• An opportunity to contribute to patient safety and pharmaceutical treatments.

• A passionate and collaborative team of experts.

• An inclusive culture where every voice is valued.