Guarantee the respect of all quality standards requested by the clients and by the norms in force, through the guidance, coordination, and control of the activities related to QC analytical operations area with impact on: validation of the company processes, control of the working areas, products quality control, procedures definition, verification of quality compliance, audit management, staff training, in respect of the norms in force (current EU GMP, US GMP), indications contained in the dossier and company standards and quality.

Batch release

• Support the QP with the verification of the application of the GMP, through the coordination and supervision of the chemical laboratories (PDS and DPS) when executing the quality controls of the incoming raw material, semi finished products,clinical batches and outbound products, with the execution of stability tests, environmental testing, the analysis certifications and the investigation, documentation and approval of possible deviations, in respect of the norms in force (current EU GMP, US GMP), and the company quality standards.

Reporting structure management

• Ensure the guidance, coordination and control of the reporting structure, by defining the objectives, exploit the results, analyzing the training and development needs, in order to guarantee a high level of performance and motivation.

• Provides strategic vision and expertise for establishing and managing the assigned Quality Control organization.
• Establishes department goals and objectives in line with Corporate and site goals.

People

• Manages all aspects of the people process including, hiring, on-boarding, performance management and employee development.

Culture of data interpretation and Compliance

• Ensure the spreading of a culture based on data interpretation, through a coaching, in order to highlight the importance of the data meaning as a risk towards clients, according to the norms in force (current EU GMP, US GMP).

• Ensure quality metrics and key process indicators are identified, measured and actioned The metrics shall measure the overall health of the system, identify areas of risk, and mitigation plans and are included (where appropriate) in the management review process.

• Ensure Data Integrity & Data Goverance in line with quality standards and site programs.

• Ensure the required support during regulatory/clients’ inspections.

Relations with Corporate

• Keeping contacts with Corporate Quality’s structure, by sending periodic reports on quality KPIs and/or issues with potential impact on production.

Relations with Clients

• Guarantee, in cooperation with other site functions, a high level of customer satisfaction considering the budget defined, the company KPI and following the OE principles.