Quality Assurance Director - GMP ESO Biotechnologies

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.
• Ensure compliance with relevant Good Manufacturing Practices and applicable national and international regulatory directives.
• Manage a team to support the activities cited above.

Essential Duties and Responsibilities

• QA operations, QA oversight of Bio-Manufacturing ESOs
• In accordance with company SOPs, implement governance, operational/interaction models with ESOs and follow their KPIs.
• Implement the investigation of deviations, OOS, complaints when these QEs refer 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, liaise with departments of: medical, pharmacovigilance and/or materiovigilance.
• Ensure all CAPAs related to the above are closed in due time.
• Implement Change Control from CMOs with implementation in Recordati QMS.
• Implement the Annual Product Quality Reviews (APQR) program in connection with the external manufacturers, for each product on time.
• Manage the Stability Program of the products, and monitor trends.
• Review production batch files in accordance with the relevant marketing authorization dossier where applicable.
• Where applicable, execute the Batch GMP certification for US / other market GMP release of the Biotechnologies product portfolio.
• Implement Routine governance inclusive 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.
• Manage budget related to External Biomanufacturing activities.
• QA supporting MSAT
• Provide review and approval of related QA documents (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.
• Communicate audit findings to audit stakeholders ensuring understanding as well as collaborate 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 disciplines 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.
• Develops an understanding of different organizational departments and functions.
• Keeps 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

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.