• Senior Manager, TPP Quality Assurance

    Job ID
    11268
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Quality
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The FHCRC Quality Assurance department (“QA”) oversees compliance with the Food and Drug Administration’s cGMP, current Good Tissue Practices (cGTP) and other applicable regulations as they apply to the manufacturing and testing of pre-clinical, Phase I and Phase II biologic and cell and gene therapy products. The QA Manager/Sr. Manager, reporting to the Head of Quality for the Therapeutic Products Program will ensure timely completion of batch record review, SOP revision, deviation management and tracking along with hosting and performing external and vendor audits.

    Responsibilities

    The Quality Assurance Manager will primarily support the Biologics Production facility operations, but also continue to develop the established quality systems for the cellular processing facility.  In addition, this position will lead and champion quality system integration between the CPF and BPF. The QA manager will interact with manufacturing personnel in the GMP Biologics Production Facility and the Cellular Processing Facility, research scientists, physician investigators, process development, Quality Control, and other scientific staff and external collaborators. The incumbent will be expected to work with project teams as a quality representative to support clinical development programs. In addition, the individual will work with project teams to ensure clinical studies and supporting activities are conducted in compliance with GxP.

     

    • Lead and champion quality system integration between the Phase I/II Cellular Processing and the Biologics Production facilities
    • Perform audits of GMP vendors against FDA regulations and ICH guidance documents.
    • Communicate compliance risks to senior management.
    • Integrate the quality assurance role into the BPF organization
    • Champion proactive identification and resolution of compliance gaps
    • Create additional quality system programs as required
    • Maintain and continuously develop the QA procedures for phase appropriate compliance with FDA, EU and other applicable regulations.
    • Provide quality assurance support to multiple areas within both manufacturing facilities
    • Provide quality assurance support for a vaccine project manufactured at a CMO
    • Support facility improvement projects
    • Perform routine quality assurance responsibilities including review and approval of executed batch records, deviation investigation reports, document change requests, CAPAs, and Standard Operating Procedures
    • Responsible for personnel management of quality associates inclusive of personnel scheduling, time management, performance management and ensuring career development opportunities in order to enhance employee retention

    Qualifications

    Required:

    • Bachelor's Degree; Master's preferred. 
    • Experience working in a regulated GMP environment.
    • Minimum of 7 years working in a Quality role within a biopharmaceutical or cellular therapy organization.
    • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
    • Independently identify and resolve complex problems utilizing functional and technical skills.
    • Manage conflict and stand alone on issues.
    • Ability to work as a team member and to work collaboratively with strong listening skills. 
    • Ability to take strategic initiatives and translate into tactical solutions.
    • Must be knowledgeable with FDA cGMP regulations and guidelines

     

    Preferred:

    • Ability to initiate and develop strategic initiatives in combination with TPP leadership.
    • Ability to utilize elements of Quality Risk Management to manage and control risk. 
    • Good listening skills, interpersonal savvy, and peer relations.
    • Ability to effectively present complex data and strategy to large groups.
    • Proven track record in developing or leading teams.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed