Quality Assurance Director - GMP ESO Biotechnologies

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values - Better Together, Never Settle and Always Deliver - reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values - Better Together, Never Settle and Always Deliver - reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Reporting Structure

Reports To:

Sr Director Quality CMO - RD

Direct Reports: 2 reports in Europe

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

Overview

The QA Director GMP ESO Biotechnologies is responsible for the QA operations oversighting 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.

Essential Duties and Responsibilities

QA operations, QA oversight of Bio-Manufacturing ESOs

In accordance with company SOPs, QA Director is responsible and accountable:

* 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.

QA supporting MSAT

* Be…