Senior Director/Head, Quality Assurance in Cambridge, MA US at Apex Systems

    Apex Systems
    Cambridge, MA 02139
    Full-time
    Similar jobs pay $11.00 - $24.52

    Job Description

    Senior Director/Head, Quality Assurance 1069386

    Job Scope and Purpose:

    Our Cambridge based clinical-stage client, who is using a novel class of biologics to engage and modulate T-cells for oncology and autoimmune targets, is seeking a Senior Director, Quality Assurance to lead the quality function. The ideal candidate will build out our clients quality systems, deliver GXP compliance strategies, lead auditing initiatives, and provide quality support for all clinical development programs. A candidate with previous exposure to regulatory filings, or managing regulatory consultants, would be preferred. For more information about this exciting leadership opportunity, please contact Todd Jamison!

    Primary Job Responsibilities:
    • Develop and lead compliance strategies for GMP, GLP and GCP, while providing quality advice and support for all clinical development programs
    • Develop and implement risk mitigation measures, standards, policies and procedures for GXP compliance
    • Provide guidance to cross-functional teams to ensure GXP compliance, while serving as a Subject Matter Expert for interpreting GXP and ICH regulatory expectations and requirements
    • Oversee the build of internal quality systems
    • Contribute to IND, IMPD and CTA regulatory filings
    • Plan and oversee all domestic and internal compliance audits for GMP, GLP and GCP to identify compliance risks and determine compliance status, while recommending to management resolution solutions on audit findings and implementing and documenting audit resolutions
    • Manage QA review of GMP manufacturing, including batch records, product release, stability testing, validation reports and essential clinical study documents
    • Assist in evaluating and selecting contract manufacturing and analytical testing sites, CROs and other service providers critical to supporting ongoing clinical development programs
    Primary Job Requirements:
    • A relevant degree (BS minimum, advance degree preferred) in a scientific discipline with at least 15 years' QA experience with protein based biologic programs
    • Hands-on experience building and managing quality systems for sterile biologics products to support global clinical trials
    • Ability to interpret and apply FDA, ICH and GLP regulations, guidelines and best practices
    • Experience acting as a regulatory agent to support IND, IMPD, CTA and other regulatory filings is preferred
    • Experience in planning and conducting GMP, GLP and GCP audits
    • Ability to use a phase appropriate approach to assess product quality and regulatory compliance during the review and disposition process
    • Experience developing and maintaining Quality Management Systems such as documentation and record management, change control, deviations, investigations, training and CAPA programs
    • Experience reviewing and auditing study-related documentation such as non-clinical and clinical study report, and investigator brochures
    • Ability to travel domestically and internationally to vendor and partner sites as needed to support product development activities and corporate partnerships
    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.

    tjamison@stratacuity.com

    Code: TechOps

    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 employeeservices@apexsystemsinc.com or 844-463-6178.

    Posting ID: 559413716Posted: 2020-06-03