Quality Assurance Director - GMP ESO Biotechnologies

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 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)

Audit/Inspections

• 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.

Additional Responsibilities

• Maintain an understanding of RRD Pharma working practices and SOPs, ensuring international guidelines/standards are met across the organization.
• Perform additional duties as may be assigned.

Education and Experience

• 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.
• Second European language an advantage but not essential
• 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

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• Location: Bridgewater, NJ (Headquarters)
• Hybrid: Minimum of 3 days onsite per week
• Travel: Up to 25%, including domestic and international travel (Canada and Italy)

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate based on any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodate for qualified individual with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

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