Quality Assurance Manager con Inglese

The Client Quality Officer is primarily responsible for the implementation and maintenance of the quality system and training for their assigned client projects. Thus ensuring that the project maintains compliance with global regulations legislation PrimeVigilance and client requirements.

The Client Quality Officer will have direct oversight of all client quality related activities for their project. They will work closely with the Quality Management Quality Assurance and Audit Management teams to ensure all aspects of PrimeVigilances and the Clients Quality Management System are being adhered to by the project. They will work closely with the Project Manager and Project Team to ensure seamless delivery of all aspects of the Quality Cycle.

The Client Quality Officer will be expected to manage a variety of clients and would be expected to deliver work with of limited input.

The Client Quality Officer will ensure the timely and complete training of employees within client projects.

The Client Quality Officer will create and maintain a project specific quality management plan for each of their assigned projects.

Review the weekly and monthly regulatory intelligence reports and assess impact on designated projects.

Ensure all project related procedures are aligned and comply with global Pharmacovigilance regulations and guideline. Review and contribute to all project related procedural documentation to ensure that all activities within the scope of work are supported by fully implemented SOPs or other documentation.

Ensure that all resources on the project are sufficiently qualified and that all project team members keep their CV JD and training records up to date.

Ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for project activities and systems and that such plans are tested regularly.

Review and approve access requests to controlled systems (PACS) used for the project.

Ensure that all backup recovery logs and audit trails for project-related systems are regularly reviewed.

Create and maintain a project specific training plan and training matrix in conjunction with the Project Manager.

Review and approve all project specific training materials created by PrimeVigilance.

Monitor timely completion of training by project team review competency based tests and sign off team members for live work.

Gather review and monitor project specific metrics and KPIs. Author quality and compliance sections of the project monthly report.

Perform final time quality review on a sample of fully processed cases each month to ensure that quality standards are maintained.

Ensure that project is inspection ready at all times.

Act as the main point of contact for all audit related activities for the project and work closely with the Audit Management team to compile pre-audit requests host all client audits coordinate all responses to audit findings and ensure completion of all proposed actions.

Contribute to any risk assessment activities performed by the Quality Assurance team for the project.

Work with project team members to ensure that deviations are reported appropriately providing support with root cause analysis categorisation.

Manage all project related deviations and CAPAs to ensure timely completion.

Strong previous pharmacovigilance experience including quality and compliance experience within a GxP environment

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Training and career development opportunities internally

Opportunity to work with colleagues based all over the world with English as the company language

Quality

Remote Work :

Full-time