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    • Compliance Manager - Fremont - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Fremont

    1 month ago

    Default job background
    Description

    Compliance Manager - Cell Therapy Manufacturing

    Novo Nordisk is a global healthcare company dedicated to discovering and developing innovative medicines for people with diabetes.

    The Position

    The Compliance Manager ensures manufacturing processes comply with regulations and standards. This includes ATMP, 21CFR, cGMP, ISO, and Corporate/local SOPs and MBRs.

    Key Responsibilities

    • Provides guidance and support to the manufacturing team to ensure ongoing compliance with regulatory and internal requirements.
    • Conducts risk assessments to identify compliance gaps and develops mitigation strategies.
    • Drives systematic problem-solving (SPS) for investigations and uses metrics and trends for process improvements.
    • Generates change controls, performs risk, and impact assessments.
    • Coordinates and documents manufacturing quality events, including deviations and Change Controls.
    • Leads investigations for manufacturing quality events and brings them to a resolution as primary author of deviation reports.
    • Utilizes problem-solving methodologies such as go, look, see by going to production areas for data gathering.
    • Leads meetings, aligning internal review teams and area subject matter experts on an agreed-upon investigational path forward.
    • Works closely with the manufacturing team to review and evaluate quality event information and trends.
    • Authors, revises, and reviews controlled documents in accordance with cGMP standards.
    • Leads activities for audits and inspection readiness, representing manufacturing in internal and external audits.
    • Provides periodic review of department documentation and records to assess for compliance with internal and regulatory requirements.
    • Stays updated on relevant regulations and guidelines in the cell therapy manufacturing industry.

    Requirements

    • Bachelor's degree preferred, with 7 years of relevant experience.
    • Minimum of three years of proven leadership experience in driving compliance and continuous improvement within Biotechnology or Pharmaceutical organizations.
    • Ability to communicate effectively with all levels of the organization and cross-functional teams.
    • Experience writing investigation, deviations, change control documentation, technical reports, batch records, standard operating procedures, and other cGMP documentation.
    • Proven capacity to work autonomously while remaining open to input.
    • Demonstrated ability to identify, challenge, and implement potential improvements to work procedures.
    • Highly motivated and comfortable working in a results-oriented dynamic research and development environment.
    • Excellent leadership, communication, presentation, and interpersonal skills.

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

    Estimated Salary: $120,000 - $180,000 per year

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