Career Opportunities

Associate Manager/Manager, Quality Assurance Inspection Management

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: This position is an integral part of the team that manages inspections through the prep, performance and follow up of items requested by international regulators. It supports regulatory inspection and partner audits in the creation and management of inspection content ensuring it is organized, current and readily accessible during operations. This position will help cross-functional teams prepare for and follow up on inspection items as well as performing duties in support of site inspection readiness.
The individual will work with department leaders to build an inspection readiness capability across the organization.

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

Inspection Readiness:

  • Support and lead teams implementing practices and improvements to make IOPS inspection-ready at all times.
  • Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
  • Build and implement tools to improve IOPS inspection readiness; determine system improvments.
  • Track internal findings and communicate updates, metrics and outstanding items to senior personnel when necessary.


Inspection Execution:

  • Liaison with partners on audit/inspection and quality related matters to provide guidance and advice.
  • Respond to incoming inquires during inspections and audits and ensure timely and accurate responses. 
  • Participates on internal committees/teams, as required.
  • Provide advice and direction to company departments on quality and regulatory issues.


Additional Responsibilities:

  • Cross-site (Tarrytown, Raheen) support of inspection readiness and inspection activities.
  • Coordinate Regeneron information to support regulatory requests for paper inspections and/or observation responses.

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