Quality Assurance Director - GMP ESO Biotechnologies

Recordati•Bridgewater, NJ

61d•Hybrid

About The Position

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? 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.

Requirements

Bachelor in Science, in technical disciples such as Pharmaceutical, Biotechnology Manufacturing, advanced degree preferred.
Minimum 15 years of professional experience in pharmaceutical Biomanufacturing.
Clear understanding of the environment, regulations and constraints of the pharmaceutical industry.
Very good knowledge of English (written and spoken).
Demonstrate leadership in working with subordinates, peers and superiors in a multicultural environment.
Autonomy in daily activities.
Willingness to travel including overnight stays.
Foster team development, and collaborations.
Manage management meetings.
Facilitate sound decision making and problem solving.
Maintain compliance with evolving regulatory requirements across the business.
Applies specialist and detailed technical expertise.
Develops job knowledge and expertise through continual professional development.
Shares expertise and knowledge with others.
Demonstrates an understanding of different organizational departments and functions.
Keep informed of good industry practices, and those applicable to the role.

Nice To Haves

Second European language an advantage but not essential.

Responsibilities

Implementing governance, operational/interaction models with ESOs and follow their KPIs.
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.
Liaising with departments of: medical, pharmacovigilance and/or materiovigilance.
Ensuring all CAPAs related to the here above are closed in due time.
Appropriate management of Change Control from CMOs with implementation in Recordati QMS.
Implementing the Annual Product Quality Reviews (APQR) program in connection with the external manufacturers, for each product on time.
Managing the Stability Program of the products, and the monitoring of trends.
Reviewing production batch files in accordance with the relevant marketing authorization dossier where applicable.
Executing the Batch GMP certification for US / other market GMP release of the Biotechnologies product portfolio.
Implementing Routine governance incluside of periodic Quality Management Review (QMR) program in connection with their perimeter, involving KPIs and reporting to Management.
Participating in CMOs evaluation / qualification as appropriate.
Managing budget related to External Biomanufacturing activities.
Being 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).
Participating and/ or supporting 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.
Maintaining the audit plans and database (parts related to GMP activities) and follow the completion of corrective actions for the audits you have performed.
Participating to the preparation, coordination, and management of regulatory agency inspections related to External Biomanufacturing processes, ensuring responses are complete and provided in due time.
Maintaining an understanding of RRD Pharma working practices and SOPs, ensuring international guidelines/standards are met across the organization.
Performing additional duties as may be assigned.