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    Director of Quality - Los Angeles, United States - Mantell Associates

    Mantell Associates
    Mantell Associates Los Angeles, United States

    1 week ago

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    Description


    Mantell Associates are partnered with a leading CDMO organisation in their search for a Director of Quality to join their senior leadership team and build, lead and execute a quality strategy.


    Director of Quality - Responsibilities:
    Management responsibility for the quality unit, training, designing, and implementing manufacturing QA programs, and ensuring that all GMP requirements are satisfied
    Sets the vision and establishes priorities for the Quality function in alignment with regulatory requirement and the strategic direction accordance with shifting business needs
    Accountable for effectively leading, driving and managing change for the functional area in a rapidly growing, highly dynamic environment
    Directs activities of the entire Quality Organisation. Sets direction and priorities of activities. Assures completion of duties as agreed upon and understood. Final authority and responsibility for all Quality decisions
    Ensures that the right resources and skills and capabilities of people in the Quality function are developed to enable the organisation to be flexible/adapt to the dynamic business conditions
    Maintains internal quality system documentation, change control, specification, validation systems managing CAPAS and non-conformance to assure compliance to cGMP. Assures systems are in place to appropriately identify, review scope and impact, and disposition process variations and deviations from written standards and procedures
    Maintains all necessary GMP or EH&S documentation to assure compliance to regulations. Assures Quality System and process are in place for Quality oversight
    Maintains effective internal auditing program to provide assurance that the site maintains a compliant state. Gaps identified are remediated in a timely manner to prevent recurrence
    Establishes, implements, and continuously improves multi-product strategy at site. Ensures validation programs are established and meeting regulatory and industry standards
    Final Decision maker on lot disposition (approval or reject)
    Plans, defines, sets requirements, assures implementation and organises systems to meet all GMP and client needs for GMP and QA activities
    Actively engages in the identification, sharing and adoption of shared practices between sites/offices. Implements/supports business process for continuous improvements in all areas of manufacturing
    Evaluate and maintain microbiological control strategies
    Manage and implement the Quality Risk Management program
    Perform other related duties and responsibilities as assigned


    Director of Quality - Requirements:
    Bachelors or Master's degree in Chemistry, Biology, or related scientific discipline and a minimum of ten (10) to fifteen (15) years of managerial experience in an aseptic manufacturing GMP environment
    Experience in a CDMO environment is preferred
    Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects
    Oral and written communication skill must be at a level appropriate for effective in-house communications, client contact and report preparation

    Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at

    #J-18808-Ljbffr
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