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Manager, Quality Compliance (Complaint Investigations)

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: November 23, 2022

Job Description:

The Post Marketing Operations department is hiring! The Manager, Quality Compliance (Complaint Investigations) will manage a team responsible for providing quality assurance oversight of site compliance focused primarily on investigation (product quality complaints and/or trend investigations) of cases received for commercially distributed and clinical products. This position will ensure compliance with general day-to-day QA support regarding documentation review and approval, while also conducting review of evidence with both internal and external records, design of experiments to test hypothesis and writing technical reports and/or protocols to support investigation conclusions. The manager will participate in cross-functional team investigations /efforts with other functions such as Manufacturing (Internal and External), Quality Control, Quality Assurance, Global Patient Safety in accordance with mandated regulatory requirements and site expectations and acts as an advisor to these groups of how to maintain and improve complianceAs a Manager, Quality Compliance (Complaint Investigations), a typical day might include the following:

  • Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; this work may be done through direct reports.
  • Oversees investigations (product quality complaints and trending) related to dissatisfaction by end user related to commercial and clinical products.
  • Provides guidance on investigation plans related to complaints documentations, photographic evidence, return samples and is available support investigations.
  • Participates in regulatory and customer audits.
  • Identify gaps in systems and develop feasible plans for correction
  • Mentor direct reports and functional area counterparts in compliance requirements.
  • Facilitating continuous improvement initiatives specific to function.
  • Ensuring appropriate training programs are implemented for related to function.
  • Knowledge/exposure to Root Cause determination methodologies
  • Proficiency in Microsoft Office programs
  • Excellent organizational skillsIn order to be considered for this position, you must hold a BS/BA in scientific discipline and
    • Associate Manager: 6+ years of relevant work experience in pharmaceutical or related industry
    • Manager: 7+ years of relevant work experience in pharmaceutical or related industry
    • Previous experience authoring investigations and managing people desirableDoes this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually) $86,900.00 - $166,000.00

Keywords: Regeneron Pharmaceuticals, Inc., Troy , Manager, Quality Compliance (Complaint Investigations), Executive , Troy, New York

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