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    Director, Quality Management Systems - Cambridge, United States - Stratacuity

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    Description

    Director, Quality Management Systems Location:
    Boston,MA (Hybrid / Onsite)

    Therapeutic Area:
    Small molecule

    Pharma Job Overview:

    The role requires leading the development, design, and maintenance of the Quality Management System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.


    Primary Job Responsibilities:
    Ensure compliance with cGXP regulations by evaluating and advancing quality standards
    Oversee the design, development, and maintenance of Global GxP e-Quality Systems aligned with business processes
    Manage the corporate cGxP training program and collaborate with department heads to develop training curriculums for GxP personnel

    Primary Job Requirements:
    Bachelors Degree in Life Sciences or a related field
    A minimum of 10-12 years of increasing responsibility in cGMP/Quality Management Systems
    Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS
    Candidates must have prior experience in FDA regulated environments and familiarity with Health Authority regulations and guidance

    About Stratacuity:

    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.

    We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer.

    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.

    Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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.

    EEO Employer
    Apex Systems is an equal opportunity employer.

    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.

    Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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 or

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