Mitsubishi Tanabe Pharma

  • Senior Director, Quality Assurance

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1192
    # 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 Senior Director, QA is responsible for managing and developing a QA team, 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 in North America, encompassing drugs, medical devices and ancillary products. The incumbent will also drive the continuous improvement of quality systems and policies to optimize effectiveness and efficiency of the overall supply chain.

    Responsibilities

    • Directs, develops and mentors a high-performing team of QA professionals.
    • Serves as QA representative on various committees and project teams.
    • Develops new policies, as required, for the U.S. team (with business in U.S. and Canada). When possible, adapts policies from global HQ.
    • Draws on deft project management skills to manage multiple projects to budget and timeline. Projects may be focused on QA procedures, processes, and systems and pertain to a broad range of products (drugs, medical devices and ancillary products.
    • Oversees manufacturing of products from a QA perspective: reviews/approves manufacturing documents and validation documents for regulatory compliance; investigates and resolves any manufacturing deviations, GMP or system issues.
    • Oversees lot disposition, release and shipping of final product including related coordination with manufacturing sites to coordinate standard lead times and other factors.
    • Partners with Supply Chain Director and Third-Party Logistics (3PL) provider to ensure consistent product supply for the North American market.
    • Initiates and maintains Quality Agreements with a range of suppliers/partners.
    • Oversees SOP reviews and directs the update of procedures as needed.
    • Organizes, leads or oversees an array of internal audits and external audits (e.g., manufacturers, suppliers, packagers, warehouses, specialty pharmacies, etc.)
    • Reviews and updates the company’s established product recall system, as required, which will be used in the event of a recall issue.
    • Ensures timely assessment and closure of discrepancies, change controls requests and lot hold events, coordinating with other functions as required.
    • Provides support for proposed changes to systems, procedures, methods, and when required, submissions to regulatory agencies, as appropriate.
    • Establishes and oversees quality metrics/reporting and utilizes for continuous improvement.

    Qualifications

    • Master’s degree in a technical discipline (Chemistry, Microbiology, Engineering or similar). 
    • PharmD preferred. 
    • Minimum of 15 years of experience in quality assurance or related field within one or more biotechnology, biologics, or pharmaceutical manufacturing facilities.
    • At least 10 years of experience supervising a QA team.
    • Experience overseeing QA for new company/product acquisitions is a plus.
    • Broad QA experience that encompasses drugs, medical devices such as pumps, and ancillary products (e.g., tubing) is also a plus.
    • Demonstrated knowledge and proficiency in:
      • quality assurance
      • quality systems
      • health authority regulatory requirements (21 CRF Part 11/210/211)
      • GMPs/SOPs
      • validation practices/principles
      • management of product claims/complaints
      • Corrective and Preventive Actions (CAPAs)
      • General knowledge of:
        • Manufacturing processes (particularly liquid sterile fill).
        • Equipment and utility IQ/OQ/PQ/PV.
      • Highly skilled in leading/managing internal and external audits across the full supply chain (e.g., manufacturing sites, warehouses, packaging facilities, specialty pharmacies and other partners).
      • Strong project management expertise; proven ability to manage concurrent projects to budget and timelines.
      • Excellent interpersonal, collaborative, verbal and written communication skills.
      • MS Office proficiency.
      • Willingness to travel up to 35 percent both domestically and internationally.
    • 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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