Associate Manager, QA (Product Complaints)

Regeneron Pharmaceuticals, Inc.

Posted Under: Rensselaer, New York jobs in Executive; Executive jobs in zipcode 12144
Posted On: 2020-02-14

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.Summary: Leads team responsible for the investigation of product quality complaints received for commercially distributed and clinical products. Direction includes review of complaint data and investigation reports, BPDR memos, QC reports, batch records and retains information. Provides guidance and coaching of employeesEssential Duties and Responsibilities include, but are not limited to, the following:--- Manage, train, develop, and supervise Compliance Specialists, Senior Specialists using 30-30 meetings, Ley lines and other tools--- Coordinate workload to ensure timely completion of investigation related tasks--- Plan and manage department projects --- Ensure Inspection readiness for complaint investigation related items --- Liaison with other departments as required--- Supervise day to day operations --- Identify gaps in existing processes and systems and propose solutions. Drive towards resolution.--- Review/Approve Process Compliance items within Complaint module--- Lead Root Cause Analysis discussions--- Facilitate Continuous Improvement initiatives--- Support customer and regulatory audits and inspectionsEducation and Experience:--- Requires BS/BA in scientific discipline or related field with 6+ years of Quality Assurance related work experience in biotech or pharmaceutical industry. Previous experience and knowledge of deviation management and/or complaints requirements and systems preferred. Previous leadership/management experience required.This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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