• Sr. Quality Specialist, Supplier Quality

    Job ID 2019-1592
    Job Locations
    US-CA-Seal Beach
    Category
    Quality
  • Overview

    To ensure Dendreon GMP Suppliers including: Contract Manufacturers, Protein Synthesis, Sterile filling, Components and Service Providers are compliant with Local and Federal regulations including Dendreon specifications and standards.  

    Responsibilities

    Responsibilities:

    • Work closely with Sourcing/Procurement and Operations to ensure and manage the Quality of Supplier Goods (Raw Materials) produced by GMP suppliers, Contract Manufacturing Organizations (CMOs) and Service Providers.
    • Ensure appropriate quality agreements, standards and specifications are established and maintained with Suppliers and Service Providers in accordance with local/Federal regulations and established Quality Agreements.
    • Provide and implement solutions to Supplier and CMO issues that arise which could impact compliance to applicable regulations and Dendreon Quality Systems (including escalation to Leadership).
    • Execute Quality System external audits of CMO’s, Raw Material Suppliers, and Service Providers. Review responses and associated CAPA to assure proper mitigation.
    • Interface, as necessary, with external auditors including officials from the US Food and Drug Administration and other international regulatory authorities as required.
    • Strategize with key departments stakeholders to ensure timely completion of all supplier quality objectives and milestones.
    • Lead projects as assigned by the Manager of Supplier Quality.

    Scope:

    • An experienced Quality Professional with significant GMP experience within Supplier Quality, Quality Engineering, Auditing, and supplier relationships management.
    • A leader and problem solver who works with abstract ideas or situations across functional areas of the business internally and externally to resolve challenging Supplier issues.
    • Maintain and build effective relationships with key internal stake holders (Site Quality, Procurement, and Operations) with regards to supplier Quality.
    • Provide GMP Suppliers and Service Provider criticality classification including:  Risk Assessments, Risk mitigation planning, and monitoring.
    • Assess and evaluate supplier changes from a quality perspective.
    • Maintain and Manage Supplier external audit schedule and for cause audits.
    • Perform routine onsite audits/assessments at suppliers and CMO facilities.
    • Author and maintain up to date Supplier and Service Provider Quality Agreements
    • Report Supplier Critical Quality Metrics to Management.

    Qualifications

    • Bachelor’s degree in a scientific discipline (Engineering/ Chemistry/ Biochemistry) or equivalent
    • 5-10 years of related experience in cGMP/FDA regulated industry.
    • Strong and demonstrated knowledge of FDA regulations and guidance for Good Manufacturing Practice in a pharmaceutical environment.   
    • Strong verbal and written communication skills.
    • Proficient in MS Office applications.
    • Well-developed team and collaboration skills.
    • Air and overnight travel will be required 30-50% for this position.
    • Experience in project management a plus.
    • 21CFR and ASQ/ISO auditing experience a plus.
    • ASQ Certified Quality Engineer a plus.
    • Ability to gown aseptically for work in Clean Room environments.

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