Associate Director - Burlington, MA, United States - Apex Systems

    Apex Systems
    Apex Systems Burlington, MA, United States

    1 month ago

    Apex Systems background
    Description
    Associate Director - Quality Assurance (GCP/GLP)
    Associate Director Quality Systems (GLP, GCP


    Science/ Focus:

    Job Overview:

    Our client is looking to add an Associate Director of Quality Systems to support and expand on the quality management systems and processes and be a key stake holder in driving the quality culture including GCP and GLP compliance.

    Oversee the development and implementation of Quality systems including CAPA, deviation, risk analysis and change control management.
    Perform inspections and internal audits and participate in audit preparation
    Oversee qualification of equipment, systems, and suppliers
    Create, revise employee training and review SOP's and work instructions
    Oversee qualification of equipment, systems, and suppliers
    BS with 5+ years in biopharma Quality Assurance (Extensive experience within GLP or GCP preferred)
    Strong experience in Quality Systems- CAPA, deviation, risk analysis and change control management
    Experience preparing for and participating in FDA inspections is highly preferred

    Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.

    PROVEN SCIENTIFIC PLACEMENTTM

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

    If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

    We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

    If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at .We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.