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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for providing professional expertise and leadership in the Quality function. Individual will proactively identify and implement industry best practices for cGMP across Supplier and Material Quality, Validation, Document Control and GMP Auditing or other areas, as appropriate.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Defines and implements quality standards, systems, and metrics for clinical and commercial operations.
* Compiles, organizes, and presents metrics for areas of responsibility to senior management.
* Provides leadership and coaching to personnel.
* Organizes QA resources to meet goals and timings, coordinates prioritization of activities with area management.
* Performs compliance monitoring of area operations, including trending of NOEs/EOEs, and DNFs and evaluating effectiveness of corrective actions.
* Reviews customer/partner/supplier requirements and responsibilities, implements required processes/agreements, as needed, to meet expectations regarding quality.
* Participates in preparation for and execution of regulatory and customer audits. Ensures audit observations are addressed appropriately and completed on schedule.
* Ensures safety and operational standards are maintained.
* Approves various documents related to area function.
* BS or higher degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment preferred. Experience with QA systems such as change control, investigations, deviations, CAPA, document management systems, etc.required.
* Minimum 10 years experience in pharmaceutical industry; biologics experience preferred.
* Minimum 3 years experience in supervisory or managerial position.
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.