Quality Assurance Director - GMP ESO Biotechnologies

Quality Assurance Director - GMP ESO Biotechnologies

Date of Posting:
Jun 15, 2026

Business Area:
Quality

Job Type: Direct Employee

Territory: n/a

Full-Time or Part-Time:
Full Time

Seniority:
Mid-senior

Reports To:

Sr Director Quality CMO – RD

Direct Reports: 2 reports in Europe

Areas Managed: QA operations oversighting Manufacturing External Supply Organization (ESO)

The QA Director GMP ESO Biotechnologies is responsible for the QA operations overseeing Manufacturing External Supply Organization (ESO), including:

• Implementing the strategy within QA operations for the management of QA oversight of External Biomanufacturing operations.
• Be the accountable QA supporting the industrial technology transfer of the product (MSAT Projects) as applicable.
• For product quality processes according to quality standards and will ensure that all administration relating to the hereabove duty is maintained and updated as required.

In relation to this job, the QA Director GMP ESO Biotechnologies will be in charge of budget associated to the External Biomanufacturing activity in their perimeter and will manage direct report(s) in order to ensure that the tasks/activities he/she is responsible for are carried out on time and in full.

The objective is to ensure compliance of these activities with relevant applicable Good Manufacturing Practices, as well as with applicable national and international regulatory directives.

In this role, the QA Director GMP ESO Biotechnologies will be responsible and accountable to manage a team, in order to support the activities cited here-above.

QA operations, QA oversight of Bio-Manufacturing ESOs

• For implementing governance, operational/interaction models with ESOs and follow their KPIs.
• For implementing the investigation of deviations, OOS, complaints when these QEs refers to the quality of the products, ensuring their correct and complete registration, participating in the completion of the investigation and the closure in due time, with recording in Recordati QMS.
• Where applicable, for liaising with departments of: medical, pharmacovigilance and/or materiovigilance.
• For ensuring all CAPAs related to the here above are closed in due time.
• For the appropriate management of Change Control from CMOs with implementation in Recordati QMS.
• In their perimeter, for implementing the Annual Product Quality Reviews (APQR) program in connection with the external manufacturers, for each product on time.
• For the Stability Program of the products, and the monitoring of trends.
• For reviewing production batch files in accordance with the relevant marketing authorization dossier where applicable.
• Where applicable, for executing the Batch GMP certification for US / other market GMP release of the Biotechnologies product portfolio.
• For implementing Routine governance incluside of periodic Quality Management Review (QMR) program in connection with their perimeter, involving KPIs and reporting to Management.
• Participate in CMOs evaluation / qualification as appropriate.
• For managing budget related to External Biomanufacturing activities.

• Be the accountable QA supporting the transfer of industrial technologies (MSAT Projects) as applicable.
• Providing review and approval of related QA document (i.e. Validation protocols and reports)

• Participate and/ or support the execution of external and internal audits to assess compliance with GMP requirements and company standards for other activities.
• Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
• Maintain the audit plans and database (parts related to GMP activities) and follow the completion of corrective actions for the audits you have performed.
• Participate to the preparation, coordination, and management of regulatory agency inspections related to External Biomanufacturing processes, ensuring responses are complete and provided in due time.