Auto req ID: 1744BR
Job Posting Title: Associate Director Quality Assurance Batch Disposition and Operations
Person Type: Regular
Posting Category: QA, QC & Quality Auditing
Job Summary and Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Responsible for providing professional expertise and leadership in the Quality function. Individual will proactively identify and implement industry best practices for cGMP across manufacturing, quality control, materials management and validation. Individual will play a major role in the transition to a more commercial manufacturing operation while remaining adaptable to the changing needs of the clinical programs. Individual will have oversight of all batch disposition materials for commercial and clinical operations.
Essential Duties and Responsibilities include, but are not limited to, the following:
Owns and continuously improves the batch disposition of Quality in the Industrial Operations and Product Supply organization
Interacts with critical biotechnology commercial and clinical API and Fill/Finish manufacturing operations, facilities and Quality Control laboratories to ensure a successful compliance profile
Defines and implements quality standards, systems, and metrics for clinical and commercial operations.
Ensures that products adhere to tight internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world
May be involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addresses and completed on schedule
Partners with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfaces with customer/partner quality organizations, and negotiates third party contractor and supplier quality agreements
Authorizes significant deviations to established, approved procedures, provides guidance to assist co-workers with troubleshooting investigations and problem resolution
Ensures safety and operational standards are maintained.
Experience and Required Skills:
Education and Experience:
BS or higher in life sciences; CQE a plus; minimum of 10 years experience in the pharmaceutical/biotechnology industry (biotech preferred); prior experience in a managerial capacity with QA/QC, as well as technical experience in a manufacturing operations function and experience with facility start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.