Career Opportunities

Manager, QAA Validation

Posted on: Friday, July 13, 2018
Organization: Regeneron
Location: Rensselaer, NY
Description:
Position Summary

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 the development and maintenance of the Quality Assurance Agreement (QAA) program, such that QAAs are established either between Regeneron and contracted organizations and partners, or within Regeneron (e.g. between Industrial Operations and Product Supply (IOPS) facilities).

Essential Duties and Responsibilities include, but are not limited to, the following:

• Developing and maintaining procedures to facilitate QAAs.

• Working with external sites and within Regeneron to facilitate QAAs in order to establish understanding of quality responsibilities and other applicable quality agreements.

  • External sites may include
  • CMOs
  • Contract laboratories
  • Raw material manufacturers, suppliers and distributors
  • Partners

• Establishing and maintaining relationships with relevant sites.

• Working with Regeneron QA and legal teams to facilitate QAAs.

• Maintaining a database of past and current agreements and their expiration dates.

• Manages a team to achieve objectives as stated above.

• Resolves problems, identifies issues and determines system improvements.

• Attend meetings relevant to assigned projects as needed.

• Lead special projects as assigned.

• Ensures team members are adequately trained for each area of review, as applicable.

Requirements:

Education and Experience:

• Requires BS/BA in Biology, Chemistry, or Life Sciences with 8+ years of GMP related experience.

• Experience in cGMP operations and personnel or project management is preferred.

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.

Apply Now

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