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    Associate Director of Quality Assurance - Burlington, United States - Kelly Science, Engineering, Technology & Telecom

    Kelly Science, Engineering, Technology & Telecom
    Kelly Science, Engineering, Technology & Telecom Burlington, United States

    4 weeks ago

    Kelly Science, Engineering, Technology & Telecom background
    Description

    Kelly Science is seeking a Associate Director of Quality Assurance for a client located near Burlington, MA.

    This is a full-time, onsite position.

    Salary:

    $125,000-185,000/year depending on experience

    Responsibilities:

    • Drive expansion of the Quality Management System(s) in the US.
    • Lead and participate in third party and regulatory audits including preparation and responses.
    • Oversee qualification of equipment, systems, and suppliers.
    • Organize and supervise employee training.
    • Create, revise, and review documents such as SOPs and work instructions.
    • Oversee and develop CAPA, deviation, risk analysis and change control management.
    • Communicate with domestic and international pharmaceutical and life science customers and auditors.
    • Interacting, reporting, and collaborating with PGN Global QA team.
    • Conduct QA in the companys programs, including ensuring Data Integrity in processes, data packages and reports to the Companys external pharma and gene therapy partners.
    • Ensure appropriate definition, development, and implementation of Quality systems.
    • Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
    • Report on Key Quality Indicators (KQI) to track systemic issues and gaps to drive on-going continuous improvement.

    Job requirements

    • Scientific or Engineering Degree (BSc, MSc).
    • Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy.
    • Extensive experience with GCP/GLP compliance required.
    • Ability to drive cultural changes and establish a strong quality mindset within the organization.
    • Experience in preparation and participating in inspections by the FDA is and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
    • Experience leading the accreditation/certification procedures for CAP/CLIA is desirable.
    • Strong quality awareness and ability to apply quality knowledge in practical work.
    • Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.
    • Experience in a people management role is strongly preferred.
    • Prior experience collaborating with outside clients and regulatory bodies preferred.
    • Excellent verbal and written communication, organizational, and critical thinking skills.
    • Strong interpersonal skills and the ability to work independently and collaborate in a team setting.
    • Attention to detail, execution of tasks, and accountability a must.
    • Must be flexible, willing to take initiative, and highly collaborative.
    • Integrity, commitment, and a motivated work ethic.
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