Full-Time

Manager – GD Quality Standards & Continuous Improvement

Gcp

Confirmed live in the last 24 hours

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops medicines for serious diseases

Biotechnology
Healthcare

Compensation Overview

$110.9k - $181.1kAnnually

Senior

Westchester County, NY, USA + 3 more

More locations: Uxbridge, UK | Berkeley Heights, NJ, USA | Tarrytown, NY, USA

This is a hybrid position with a requirement of 3 days on-site.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Google Cloud Platform

You match the following Regeneron Pharmaceuticals's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Knowledge, understanding and application of GCP, and/or GVP guidelines including the management of fundamental quality issues and compliance activities.
  • Knowledge and understanding of quality management system (QMS) oversight, governance of quality processes, quality event oversight and continuous improvement.
  • Effective management of interpersonal relationships and collaborations.
  • Experience serving as a subject matter expert/process owner/business process owner in a quality related field/area.
  • Experience in providing training and presenting information on key quality and regulatory compliance information.
  • Bachelor's degree with a minimum of 6 years of relevant healthcare/pharmaceutical industry experience. Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc..), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).
Responsibilities
  • Supporting the engagement of key stakeholders across Global Development functions to proactively identify process improvements, standardizations and regulatory compliance that impacts the Regeneron Global Development quality system.
  • Responsible for managing the reporting and provision of quality-related metrics and trends to enable functions to continuous improvement.
  • Responsible for managing the Quality Event (QE) portfolio and the provision of Subject Matter Expert (SME) expertise and guidance to relevant functional areas.
  • Responsible for governance and oversight activities, including facilitation of oversight meetings and preparation and presentation of data supporting the health of the QMS.
  • Responsible for championing of the Quality Management System, including increasing awareness of the QMS within Global Development to influence quality culture.
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often collaborating with academic institutions and other pharmaceutical companies to enhance its development efforts. Unlike many competitors, Regeneron focuses on both research and commercialization, generating revenue through the sale of its approved medicines and licensing its technologies. The goal of Regeneron is to improve patient outcomes by providing effective treatments and ensuring that its products meet high safety and efficacy standards.

Company Stage

IPO

Total Funding

$684M

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Growing antibody therapy market offers expansion opportunities for Regeneron.
  • Investment in Truveta's genome project accelerates personalized medicine initiatives.
  • Acquisition of Oxular strengthens Regeneron's position in retinal disorder treatments.

What critics are saying

  • Class action lawsuit may lead to financial liabilities and reputational damage.
  • Truveta investment might not yield expected returns, posing financial risk.
  • Integration challenges with Oxular could affect operational efficiency.

What makes Regeneron Pharmaceuticals unique

  • Regeneron leverages proprietary technologies for innovative therapies in serious diseases.
  • Strategic collaborations enhance Regeneron's research and development capabilities.
  • Regeneron's focus on eye diseases and monoclonal antibodies sets it apart.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours