• LFB USA - Director External QA

    Job Locations US-MA-Framingham
    Job ID
    2018-1325
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    The Director of External QA will develop and provide strategic direction in the implementation of quality strategies, policies, procedures and optimal infrastructures to ensure all external CMOs/CTLs are in compliance with all regulatory agencies, i.e., FDA, EMA, etc. This position is primarily responsible for all quality assurance aspects relating to quality oversight of drug substance and drug product manufacturing, including packaging/labeling and testing programs and requires a wide range of skills across the quality function to allow for flexibility as the goals and objectives shift to fit the organization's needs.

    Responsibilities

    • Drives, leads and troubleshoots quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
    • Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections.
    • Performs quality review of documents from contract manufactures for compliance with LFB policies and procedures.
    • Implements and monitors vendor management key performance indicators at contract manufacturers.
    • Ensures ongoing operations quality checks at contract manufacturers for: 1) Drug Substance, Drug Product Manufacturing, Packaging & Labeling operations, and Materials Control; 2) Proper contamination control; 3) Good Documentation Practices; 4) Adherence to approved batch record instructions 5) Physical product quality.
    • Troubleshoots product quality defects and AQL failures.
    • Ensures LFB USA Good Distribution and Transportation Practices at contract manufacturers and provides periodic monitoring for compliance.
    • Provides audit support of LFB USA contract manufacturers as required.
    • Aligns contract manufacturers with LFB continuous improvement programs.
    • Identifies, designs and implements process and system improvements.
    • Establishes Quality Agreements with CMO's (assuring agreements are established before projects are initiated).
    • Reports on performance at CMOs for overall site metrics, key issues to be presented at the QMRC meeting.
    • Manages competing priorities and allocates and assigns department resources to meet targets and timelines.
    • Reviews, approves, and tracks all CMO change controls.
    • Performs CMC reviews and annual product reviews.
    • Drives the use of strategies, technologies, resources and processes in support of quality initiatives. Leads the effort to apply risk management and risk assessment tools and strategies.
    • Manages Quality Transfer activities with contract manufacturing and testing laboratories.
    • Drives continuous improvement both internally and at CMOs including improvement of contracts, Business review metrics, Quality Agreements.

    Qualifications

    • BS, MS or equivalent experience (1O+ years) in QA pharmaceutical / biotechnology, with clear practical understanding of GXPs.
    • Hands-on and must possess a working knowledge of all business disciplines to ensure ability to 'partner' with all functional departments of the organization.
    • Functions at the strategic level as well as the tactical. Knows when to dive into the details, and get involved.
    • Must understand the value of constructive engagement and have the confidence to challenge and be challenged internally and externally to get the best possible strategies and solutions.
    • Must Be capable of supporting the QA Operations function to successfully meet the company's clinical and commercial needs in a compliant fashion.

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