Our client is a a global biopharmaceutical company providing products and services for cancer treatment to hospitals

They are currently looking for a member of the Senior management team in CEE in charge of QA management in the Czech, Slovak and Hungarian markets. Due to organizational changes to be expected, they would like to offer the position on an Interim base for 6 months to be potentially prolonged.

Responsibilities of the position would include:

• guidance, support, oversight and framework for local ownership of the Quality Management Systems at the respective affiliates of the CEE region.

• quality oversight at the affiliate offices in accordance with group policies, standards, procedures for GMPs and GDPs.

• Contribute to improvement of existing processes and the development of new processes or sub-processes related to the QMS across the CEE region.

• Aligning Quality Systems strategies with the Global Quality Systems by harmonizing common concepts, assisting to SOP writing and by making recommendations for SOP revisions as applicable

• Conducting face to face GMP/ GDP trainings for affiliate quality personnel across the CEE region, upon demand from the Affiliates within the region

• GMP/GDP trainings also with other technically-related functions depending on the affiliate requirements

• Maintaining local system administrator role for DMS and LMS and assess potential impact of any changes on Global system on the Regional / Local (affiliate) Quality Systems.

• Support to quality responsible functions of Affiliates within CEE region. for Compliance systems and processes (Deviations, CAPA, Change Control, Product Quality Complaints handling, Product returns, Risk Management) in coordination with the respective QA Logistics and other Global functions.

• Ensuring Distributor’s quality management and compliance systems are adequate for the distributor’s activities and are maintained.

• Participate in CEE hub leadership meetings as the Quality representative.