Mitsubishi Tanabe Pharma

  • Sr Mgr, Quality Assurance

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1255
    # 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 Manager, Quality Assurance (QA) plays a key role in acting as a liaison between MTPA (US), MTP-CA (Canada) and MTPC (Japan). The Sr. Manager, QA is responsible for executing quality assurance activities covering product acceptance, product release, validations and qualifications, packaging/labeling, storage, distribution, document/change control, training, and post approval activities while assuring compliance with GXP regulations for US and Canada marketed products.

    Responsibilities

    • Liaises with MTPC QA, US and Canadian service providers, and importer to ensure that QA documentation and product releases are met for the US and Canada product distribution
    • Liaises with MTPC QA for release of the product to maintain stable supply to Canada and in the US
    • Liaises with MTPC QA, Medical Affairs, MTDA Drug Safety, Importer, and PQC Service Provider for PQC handling for US and Health Canada products and leads process improvement initiatives from MTPA QA perspective
    • Leads MTPC QA audit(s) and prepares responses; assists in facilitating audits conducted by regulatory agencies; manages vendor qualifications and vendor audit program; prepares yearly audit schedule; reviews audit reports and responses for accuracy and completeness and follows up on corrective actions and commitments.
    • Undertakes quality process and procedure improvement initiatives. Reviews and updates MTPA QA SOPs and ensures that current practices as applicable are included in the SOPs
    • Ensures that paper and electronic databases and log books are updated on a regular basis and as required per MTPA SOPs.
    • Manages QA electronic systems evaluation, qualification, and implementation.
    • Communicates to and follows up with service providers for discrepancies, deficiency resolutions, and product disposition.
    • Manages day to day activity of product quality complaints and returned goods evaluation in a manner that complies with MTPA SOPs and regulatory requirements.
    • Manages day to day activity of change control, deviation, product quality complaints, Corrective & Preventive Actions (CAPAs) databases and log books.
    • Provides support in preparation and management of Field Alert Reports (FAR) and potential product recalls.
    • Maintains communication with MTPC QA; promptly communicates to QA Senior Director any queries or quality issues raised by MTPC QA or other external stakeholders.
    • Manages the receiving, handling, documentation, investigation, resolution and closeout of all product quality complaints in compliance with MTPA SOPs, the FDA and Health Canada regulatory requirements.
    • Manages and coordinates returned goods evaluation with returned goods service providers and internal stakeholders
    • Prepares monthly quality scorecards, monthly reports, trending charts, meeting minutes for MTPA products.
    • Reviews and approves change controls, audit reports, product quality complaint reports, non-conformance investigations, batch records, CAPA, validation and qualification protocols and reports.
    • Participates as a QA representative on project teams or at on-site meetings as directed by Senior Director, QA.
    • Assists in training QA associates and coworkers on the daily QA activities and the company Quality System; supports the development and maintenance of the Quality System.
    • Acts as a designee for Senior Director, QA on as needed basis; assists Senior Director, QA as required; and assists other departmental team members to ensure continuity of projects and work flow.

    Qualifications

    • Bachelor’s or higher degree in a technical discipline (Chemistry, Microbiology, Engineering or similar). 
    • Minimum of 7-10 years of experience in Quality Assurance in a regulated pharmaceutical environment.
    • Experience building relationships and working with drug manufacturing and CMOs as well as auditing vendors
    • Experience in analyzing product quality trends
    • Experience in parenteral or aseptic sterile manufacturing is preferred
    • Working knowledge of ICH quality guidance and FDA and Health Canada regulations including cGMP and GDP for commercial products
    • Knowledge of commercial drug product related quality assurance activities including complaints management, product recalls, submission of FARs, audits, change control, and CAPAs
    • Negotiation, interpersonal communications skills with a good awareness of global cultural differences to effectively promote coordination between QA functions both between US entities and with MTPC Japan
    • Ability to work independently and in a team environment
    • Able to multitask, handle multiple projects at one time, and change priorities based on business needs
    • Technical writing skills in English.
    • Japanese language skills, with ability to convert documents from Japanese into English, are preferred.
    • Knowledge of computer programs such as Excel, Access, PowerPoint, and Statistical software
    • Willingness to travel approximately 10 percent domestically and internationally

    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
    • Carry, handle and reach for objects
    • Lift and pull up to 15 pounds

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