QA Project Manager

Organization: 
Regeneron
Job Location: 
Rensselaer, NY
Job Description: 

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Summary:
Accomplishes project objectives by planning and evaluating project activities. Support Quality Assurance project initiatives for a broad range of topics. The PM support may span into operations, validation and inspection management

Essential Duties and Responsibilities include, but are not limited to, the following:
- Achieves quality and operational objectives by contributing information and recommendations to strategic plans and reviews
- Preparing and completing action plans; implementing productivity, quality, and customer-service standards
- Resolving problems, identifying trends and determining system improvements
- Implementing change when necessary within the guidelines of GMP
- Maintain project timelines associated with quality assurance initiatives to support the evolving business
- Industry student to understand other company approaches to quality related projects
- Attend meetings relevant to assigned projects as needed.
- Represent quality on new projects upon request; examples, but not limited to:
- Product Release
- Inspection Preparation and Support

Knowledge and Skills:
- Interpersonal, written and oral communication skills
- Knowledge of cGMP regulations and familiarity with ICH guidelines.
- Knowledge of MS word, Excel, database management and statistical analysis
- Effectively organize and manage work responsibilities independently. Good time and project management skills with the ability to multi-task.
- Experience with documentation and quality systems.

Education and Experience:
- Requires BS/BA degree in Life Sciences or related field and 3+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

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