Quality Defects and Recall Manager, Market Compliance – Compliance

Closing date for applications: 17/02/2020

ROLE SUMMARY

Reporting to the Market Compliance Manager, the role of the Quality Defects & Recall (QDR) Manager is to proactively manage the QDR programme employee to ensure that reports of suspected Quality Defects in medicines and active substances are effectively investigated and managed on a risk-basis, predicated upon patient and animal safety. The role also includes management of the activities in relation to Exempt Medicinal Products.

The QDR Manager manages the overall performance of the QDR group by defining objectives, setting targets, coordinating activities, agreeing priorities, developing team members, maintaining effective communication lines; and ensuring that the required standards, policies and practices are in place and consistently applied. They will provide leadership, motivation, encouragement and effective management for all employees and ensure development and maintenance of a positive working environment.

The QDR Manager is required to support and be involved in initiatives with external stakeholders that promote good practices in the manufacture and distribution of medicinal products – these include speaking at external events in relation to quality defect and related issues and engaging in activities that promote compliance and good practice generally. The QDR Manager works closely with the other members of the Market Compliance section to ensure: appropriate levels of communication and co-operation and assists the Market Compliance Manager in maintaining effective working relationships with other departments/sections across the HPRA.

The QDR Manager participates in an EMA working group in relation to QDR work across Europe and the modernisation of QDR work practices across the EEA. Ensuring that this network operates effectively is essential to the appropriate management of quality defects and medicines recalls.

Applications should be submitted via the HPRA Recruitment Portal


Role Profile                HPRA Recruitment Portal application form



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