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    Director of Quality Assurance - Lawrence, KS, United States - Management Recruiters of Edison

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    Description
    Our client - a growing company with multiple plants in the US, needs a Sr.
    Director of Quality at their plant expanding to manufacture pharmaceutical products.

    Excellent salary up to $250K + Annual Bonus + Sign on Bonus + Relocation Assistance + Full Benefit Package + 4 Weeks' vacation.

    Director - Quality Location: Base of $225K - $250K per year + Annual Bonus Target of 30% + Sign-On Bonus - $15K

    Relocation:
    YES - Client offers relo assistance with a lump Sum sign on Bonus

    Benefits:
    Full package for medical, dental insurance, 401K + 4 Weeks' Vacation + 13 days - PTO, etc.

    Our client is a privately held company in business for 40 years with manufacturing sites in CA + KS with around 300 people

    Group Info:

    Be part of the medical device and pharmaceutical contract manufacturing site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.

    The new operation expansion is for Pharma Fill Finish Seal - FFS of Sterile Aseptic liquids.


    This Quality group has around 25 people from Quality control, Quality Assurance, Validation, Compliance and this position reports to the Plant - General Manager.


    The Senior Quality Director develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Pharma Biologics, while assuring systems and procedures for regulatory compliance are established and deployed.

    Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.

    Manage the batch review and release activities
    Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policies
    Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements
    Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements
    Interacts frequently with all levels of internal management as well as across functions and franchises
    Manages interactions with customers and regulators concerning the quality of products, systems, and processes
    Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
    Develops budget for plant or programs/department and ensures adherence to the budget
    Manages overall coaching, training, development, and succession plans for the team

    In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
    Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
    Extensive working knowledge of applicable quality and regulatory standards and regulations
    Experience in risk management, validation, analytics, and microbiology, within a GMP environment
    Quality expertise on tech transfer
    Bachelors of Science or Engineering or related degree
    15 years of experience in Medical Device or Pharma Industry
    5 years of Quality Management experience in the Pharma Industry
    Excellent people, communication and management skills to create a team environment
    Good leadership skills to motivate plant personnel and gain their respect

    Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.

    Advanced degree or an MBA
    Experience with remediation of Quality systems in FDA 483 or Warning Letter environment
    Knowledge of Sterile Aseptic Filling Operations
    Contract Manufacturing experience working closely with customers and clients

    BioPharma, Pharma, Quality, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant,


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