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Manager, Quality Compliance (Complaint Investigations)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
May 26, 2024

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Job Details

The Manager, Quality Compliance (Compliant Investigations) leads 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 person will ensure compliance with general day-to-day QA support regarding documentation review and approval and conducts review of evidence and both internal and external records, design of experiments to test hypothesis and writes technical reports and/or protocols to support investigation conclusions. They will also 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. They will act as an advisor to these groups of how to maintain and improve compliance and become involved to meet schedules or resolve problems.

In this role a typical day may include, but are not limited to, 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.

  • Other related responsibilities as assigned.

This role may be for you if you:

  • Have previous quality experience in the pharmaceutical industry

  • You continuously seek to improve processes for improved performance

  • Enjoy leading a team of Quality minded professionals

  • Have knowledge/exposure to project management

  • Have proficiency in Microsoft Office Programs

To be considered for this position, you must have a minimum of a BS/BA in scientific subject area or related field with the following amount of minimum experience for each level:

  • Assoc Manager, Quality Compliance: 6+ years

  • Manager, Quality Compliance: 7+ years

  • Sr. Manager, Quality Compliance: 8+ years

Previous leadership/management experience required, or equivalent combination of education and experience.

#REGNQA

Does 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)

$89,100.00 - $199,000.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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