Mitsubishi Tanabe Pharma

  • Director, Quality Assurance

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1252
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    With the recent FDA approval and availability in the U.S. of RADICAVA® (edaravone) MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients. 

     

    The QA Director is responsible for establishing and maintaining quality systems and driving a culture of quality throughout the entire Mitsubishi Tanabe Pharma America Inc. corporate environment to ensure the safety and efficacy of products. The incumbent will also drive the continuous improvement of quality systems and policies to optimize effectiveness and efficiency of the overall supply chain. The QA Director will plan and manage QA product standards and release activities and services, and manage documentation of releases and other QA issues. 

    Responsibilities

    • Works on developing new policies and updating existing policies for the U.S. team, and adapts policies from global HQ as appropriate – e.g., document management, vendor qualification, auditing, quality metrics and reporting, SOPs, etc.
    • Initiates and maintains Quality Agreements with suppliers/partners. Manages day-to-day activities for lot disposition, release and shipping of final product.
    • Compiles and reviews lot related documentation to ensure final product meets procedures, specifications and regulatory requirements.
    • Compiles and verifies lot related release documents from parent company in Japan.
    • Works in partnership with Director, Supply Chain and third-party logistics (3PL) provider to ensure consistent product supply for the US market.
    • Organizes and leads audits of suppliers.
    • Coordinates/facilitates lot disposition activities and lot disposition standard lead times at manufacturing site.
    • Prepares, reviews and approves lot disposition.
    • Establishes product recall system to be used in the event of a recall issue, (Process is coordinated with colleagues in Japan).
    • Ensures timely assessment and closure of discrepancies, change controls requests and lot hold events.
    • Communicates lot disposition pending issues to Commercial Management in a timely manner,
    • Reviews/approves manufacturing documents and validation documents for regulatory compliance as required,
    • Compiles and verifies all product lot related documents necessary for product release,
    • Supports quality investigations of manufacturing deviations, GMP issues, and system issues.
    • Reviews technical/investigation reports as appropriate,
    • Provides support for proposed changes to systems, procedures, methods, and when required, submissions to regulatory agencies as appropriate.
    • Establishes quality metrics/reporting and utilize for continuous improvement.
    • Serves as QA representative on global project teams.

    Qualifications

    • Bachelor's degree or equivalent work experience in a technical discipline (Chemistry, Microbiology, Pharmacy, Engineering or similar). 
    • Master’s degree preferred.  
    • Minimum of 10 years of experience in quality assurance or related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
    • Demonstrated knowledge and proficiency in:
      • quality assurance
      • quality systems, particularly lot dispositioning, change control and exception management
      • health authority regulatory requirements (21 CRF Part 11/210/211)
      • GMPs/SOPs
      • validation practices/principles.
    • Skilled in identifying, writing, evaluating and closing Corrective and Preventative Actions (CAPAs).
    • Skilled in the successful management of internal and external audits.
    • General knowledge of:
      • manufacturing processes
      • equipment and utility IQ/OQ/PQ/PV.
      • sterile fill & cold chain and frozen products is a benefit
    • Excellent interpersonal, collaborative, verbal and written communication skills.
    • MS Office proficiency.
    • Willingness to travel (international and domestic) up to 25 percent.

    Physical Demands:

    • Ability to sit or stand for long periods of time
    • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
    • Ability to carry, handle and reach for objects
    • Ability to lift and pull up to 15 pounds

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