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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Manager Quality Assurance

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeEast Greenbush, NY, USA$92.2k - $176k /yr

About the Job

Requirements

  • A Bachelor of Science or Bachelor of Arts degree in Life Sciences or a related field, or an equivalent combination of education and experience.
  • The Associate Manager QA level requires 6 or more years of relevant experience; the Manager QA level requires 7 or more years of relevant experience. Level will be determined based on experience.
  • Previous people leadership or supervisory experience is required.

Responsibilities

  • Manage direct reports, including performance management.
  • Provide first response for quality and compliance issues encountered on the manufacturing floor.
  • Lead, set expectations, schedule, and monitor performance standards and goals of assigned teams to ensure optimal performance.
  • Ensure teams possess the required skills and knowledge and are appropriately trained to support plant operations.
  • Ensure compliance with all regulatory requirements and good documentation practices to provide a safe, quality, and effective product.
  • Represent the Quality function and speak to area processes and responsibilities during regulatory inspections.
  • Monitor and update area procedures to ensure alignment with policies and operational requirements and to maintain quality standards.
  • Represent Quality Assurance in support of deviations, change controls, and corrective and preventive actions (CAPAs), including active participation in investigation, evaluation, and problem resolution.
  • Review, edit, or approve controlled documents; may review or approve master batch records in an electronic execution system.
  • Influence standards, challenge the status quo, and influence others to achieve results.
  • May oversee and administer visual inspection training and qualification programs.
  • Wear full cleanroom attire, which may include laundered undergarments, a gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and sanitizing agents such as IPA during the gowning process.
  • Remove jewelry, makeup, and nail adornments when wearing cleanroom attire.

Desired Qualifications

  • Knowledge of visual inspection, assembly, labeling, and packaging operations is preferred.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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