Senior Quality Specialist, Client Quality Management

About the role

Ergomed is recruiting a Senior Quality Specialist for its Client Quality Management function in Belgrade. The role is responsible for implementing and maintaining the quality system and training for assigned client projects, so that projects stay compliant with global regulations, legislation, PrimeVigilance and client requirements. The specialist manages several clients and delivers work with limited supervision.

Key responsibilities

• Oversee all client quality activities, working with Quality Management, Quality Assurance and Audit Management teams and with the Project Manager and team.
• Create and maintain a project-specific quality management plan and a training plan and matrix, and review and approve training materials.
• Ensure timely and complete training of project employees, review competency-based tests and sign off team members for live work.
• Review weekly and monthly regulatory intelligence reports, and author the quality and compliance sections of the monthly project report.
• Keep project procedures aligned with global pharmacovigilance regulations and guidelines, and ensure all project team members keep their CV, JD and training records up to date.
• Ensure Business Continuity Plans and Disaster Recovery Plans are in place and tested regularly, and review backup, recovery logs and audit trails.
• Review and approve access requests to controlled systems (PACS) and approve project-specific metrics and KPIs.
• Perform a monthly quality review on a sample of fully processed cases and keep the project inspection-ready.
• Act as main contact for audits: compile pre-audit requests, host client audits, coordinate responses to findings and follow up on corrective actions.
• Support root cause analysis, categorisation, and corrective and preventative actions (CAPA) for deviations.

Required profile

• Life sciences degree.
• Strong previous pharmacovigilance experience, including quality and compliance experience in a GxP environment.
• Ability to manage several clients with limited supervision.

Required skills

• Good organisational skills, attention to detail and excellent communication skills.
• Good IT skills.