Manager, Quality Compliance (Complaint Investigations)
Company: Regeneron Pharmaceuticals, Inc.
Posted on: November 23, 2022
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
- 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
- Mentor direct reports and functional area counterparts in
- Facilitating continuous improvement initiatives specific to
- Ensuring appropriate training programs are implemented for
related to function.
- Knowledge/exposure to Root Cause determination
- 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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