• Manager, Manufacturing Quality Assurance

    Job ID 2019-1695
    Job Locations
    US-CA-Seal Beach
    Category
    Quality Assurance Mfg
  • Overview

    Founded on the belief that immunotherapy made from a patient’s own cells holds the key to the future of cancer care, Dendreon is making the battle against cancer personal.  We are focused on improving the lives of men living with prostate cancer through the delivery of innovative immunotherapies that harness the power of the body’s immune system to extend life. We’re looking for talented people to join our team that will positively impact the lives of patients.  Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as a countrywide Commercial team, we have a diverse offering of exciting opportunities.  Backed by Sanpower, a multi-national conglomerate, we are well-positioned for transformation and growth.

    The Dendreon Values:

    Rise to the Occasion - Challenge each other to do better every day. In every situation, there is an opportunity for excellence. 

    Act As One - As one team with a shared purpose, we are strongest when we act together.

    Fight for What Matters - Our patients are counting on us. Their battle is our battle. 

     

    Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

     

    Dendreon seeks a Manufacturing Quality Assurance (MQA) Manager that is responsible for managing and hiring QA teams, support batch record reviews, and final product release. Experience in reviewing batch records to ensure records meet cGMPs and submission requirements. Ensure operations from Aph receipt to final product disposition maintain compliance that includes but are not limited to, authoring quality documents, reviewing process/method validation documents, nonconformance investigations, and managing product complaints and their investigations. Provide input into change management and risk management systems. Provide production support and guidance for cGMP product quality and compliance for product release including quality assurance management of cGMP investigations/nonconformance, associated CAPAs, and change controls.

     

    Responsibilities

    • Supports batch record review function.
    • Provides input on product disposition.
    • Establishes positive relationships and interfaces with internal departments to communicate and promptly resolve quality issues.
    • May represent QA on assigned project and product teams.
    • Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Develops, tracks and reports performance metrics.
    • Assists in nonconformance and CAPA activities, and provides general quality assurance support for the overall application of Quality Systems.
    • Assists with change control management responsibilities including impact assessments, approvals, tracking and implementation.
    • Serves as Subject Matter Expert for Quality Operations programs.
    • Performs cGMP documentation review (and approval as required) for SOPs, qualification and validation documents, quality reports, technology transfer documents, and analytical data.
    • Reviews applicable documentation as necessary prior to submission to regulatory bodies/external auditors. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested.
    • Ensures system compliance by implementing and maintaining activities for batch record review, SOP review, qualification/validation review, and technology transfer, in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and project timeline expectations.
    • Provides support for recalls and biological product deviation reports.
    • Manages complaint-handling investigations for product complaints and adverse events. Supports preparation and completion of the Annual Product Review.
    • Proactively communicates, works with and provides timely services to staff and internal colleagues in Quality, QC, Mfg, Process Science, and Supply Chain, IT, Metrology, Facilities and Training groups. Supervise, mentor and provide performance reviews for MQA staff. Routinely leads a cooperative effort among members of a project team.
    • Supports regulatory inspection readiness activities and regulatory inspections.
    • Ability to function in a fast-paced environment and anticipate/adapt to changing needs and priorities. Consistently meets performance

     

    Scope:

    • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
    • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
    • Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
    • Acts as advisor to subordinate(s) and business partners to meet schedules and/or resolve technical problems.
    • Develops and administers schedules, performance requirements; may have budget responsibilities.

    Qualifications

    • BS/MS in a relevant scientific discipline.
    • Minimum 8 years’ experience within QA functions in biopharmaceutical or pharma industry, with knowledge of parenteral, sterile products or biologics manufacturing preferable along with previous supervisory and/or leadership experience.
    • Knowledge and applicable experience with batch record review with emphasis on disposition/release, change control, nonconformance/CAPAs, SOP authoring/review, validation, and technology transfer.
    • Demonstrated proficiency and knowledge of cGMP (FDA) and ICH requirements.
    • Involvement in regulatory inspections preferred.
    • Experience leading teams, projects, programs or directing the allocation of resources.
    • Excellent organizational, interpersonal and communication skills.
    • Experience in implementation and maintenance of a Quality System.
    • Able to exercise judgment to determine appropriate corrective actions.

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