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        Director, Quality Assurance

        Mitsubishi Tanabe Pharma Development America Inc.
        Jersey City, NJ 07097
        Full-time, Part-time
        Refer friends, get paid!

        Job Description

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

        Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.

        The Director, Quality Assurance is responsible for maintaining GCP & PV quality systems and assuring a culture of quality throughout all clinical development departments of Mitsubishi Tanabe Pharma Development America Inc. (MTDA) to independently confirm the safety of clinical trial participants, the veracity of study data, and the legal protection of the company. The incumbent will also drive the continuous improvement of quality systems and policies to propose optimization of the overall development process. The Director, Quality Assurance will plan and manage QA activities such as audits, CAPAs, deviations, inspection activities and services, and to manage documentation of all QA issues. 

        Responsibilities

        • Work with Soyaku and Idayaku Departments within MTPG (as assigned) regarding Quality issues and activities and to channel communications and escalations on both a global and regional basis
        • To assume any responsibilities as requested by the Senior Director of QA, MTDA
        • Possess an awareness of current and planned clinical and PV programmes within MTDA and, as appropriate, commercial activities as related to PVG
        • Assist Senior Director in the management of MTDA QA resources to ensure adequate coverage of projects and activities
        • Provide QA input to MTDA working groups and systems development as assigned
        • Deliver advice on QA and GXP matters to all MTDA staff
        • Participate, and where necessary, lead GCP training initiatives and programs for MTDA staff
        • Liaise with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes
        • Attend relevant conferences and seminars to maintain an awareness of external QA activities
        • Conduct internal and external meetings as appropriate
        • Ownership of, and review of QA SOPs and WIs
        • Provide QA review and approval of MTDA SOPs and Work Instructions
        • Define audit schedules and plans for clinical and other audits as appropriate
        • Liaise with relevant parties to arrange the audits as required by QA audit plans
        • Prepare/ perform or manage such audits as required by the audit plans
        • Perform Internal Process Audits of MTDA processes
        • Prepare in a timely manner reports of audits performed
        • Distribute relevant audits reports in accordance with MTDA policy
        • Provide local North American perspective in relation to global activities and systems arising from MTPC and investigate other applicable regional perspectives as possible (i.e., alternate regulatory information sources)
        • To deputize as host of GCP & PV related audits and Regulatory inspections of MTDA activities

        Qualifications

        • BA/BS in Life Sciences is required
        • Masters Degree in Life Sciences is preferred
        • A minimum of ten years experience in a relevant GXP area
        • A minimum of seven years previous experience as an auditor
        • Previous personnel management experience is preferred
        • Health care/commercial compliance experience is preferred
        • Excellent communication and analytical skills
        • Detail oriented
        • Potential and willingness to develop skills related to the management of the MTDA QA function
        • Up-to-date with current global GCP and PV Regulatory requirements regarding clinical trials
        • Practical experience with agency Inspections both in-sponsor-office and at remote hospital sites (ideally US and internatonal)
        • 'Can-do' attitude and approach
        • Diplomatic and politically sensitive to departmental structures within MTPG
        • Ability to break down complex issues into simpler explanatory plans for action, whileremaining separate from day-to-day clinical dept activities
        • Complete-finisher, determined approach and yet careful and attentive listener
        • Willingness to travel up to 50% (mostlly domestic)
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        Posting ID: 564750676Posted: 2020-08-04