• Manager of Product Quality Complaints

    Job Locations US-NJ-Princeton
    Requisition ID
    2019-10829
  • Responsibilities

    Manager Complaint develops, implements and maintains complaint management system in a manner that is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving and responding to customer complaints and other post-market feedback. The complaint system will pertain to all US Quality Management of finished pharmaceutical and medical device products.

     

    • Manages the receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820)
    • Manages process pertaining to contact with healthcare professionals submitting product complaints
    • Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements
    • Creates complaint, and related CAPA trend analysis reports and submit to management to ensure early detection of potential quality issues
    • Gathers data to assist with any potential recall and/or reporting actions
    • Participates in internal audits and external quality system audits conducted by the FDA and other regulatory agency representatives
    • Monitors complaints for product trends and notify management of events requiring immediate action
    • Follow-ups with Sales Reps, Hospitals, Pharmacies and Physicians to obtain applicable information pertaining to reported events
    • Works closely with Pharmacovigilance to ensure timely completion of MDR rationales as well as initial, supplemental and final incident reports to FDA and other regulatory authorities within specified timeframes
    • Supports Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives

    Travel (approximately 10%)

    Qualifications

    Required:

    • Bachelors Degree + 6 years of Quality Assurance experience in the pharmaceutical and/or medical device industry
    • Experience in analyzing product quality complaints and determining reportability to the FDA and other regulatory agencies
    • Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations and documentation
    • Excellent analytical, problem solving, and troubleshooting skills
    • Proficient in MS Office software, TrackWise
    • Strong interpersonal and communication skills
    • Ability to work in a team environment
    • Ability to multi-task

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying creativity in everything it does.
    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 
     
    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
     
     
    Disclaimer: 
     
    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
     
    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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