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    Head of Quality - Los Angeles, United States - i-Pharm Consulting

    i-Pharm Consulting
    i-Pharm Consulting Los Angeles, United States

    3 weeks ago

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    Description
    Head of Quality - Biologics - Cell & Gene

    Head of Quality required to work for a niche Cell & Gene Therapy Biotech. Their focus has been on using a CRISPR discovery platform to decipher the genome to identify gene targets.

    Due to the success of their business, they're now growing their GMP manufacturing for late-stage clinical and commercial cell therapy.

    They consistently collaborate with some of the biggest names in Life Sciences


    JOB TITLE
    Head of Quality / VP of Quality

    LOCATION
    USA / California / Bay Area / CA

    SALARY
    $200K - $250K + bonus and package

    ROLE/DESCRIPTION
    Highly visible role reporting directly to the C-Suite to establish and grow the quality and regulatory functions for the business
    You will spearhead, implement, and develop a quality management system (QMS)
    Oversee all QA activities throughout the product lifecycle, from early clinical to commercial phase

    Be the primary liaison for the regulatory teams and ensure timely support of regulatory CMC filings, IND/IMPD and associated updates.

    Communicate regulatory requirements to internal & external stakeholders, providing guidance on compliance strategies and regulatory risks
    Conduct internal audits and oversee external audits from clients, regulatory agencies, and partners
    Recruit and develop a high-performing team of quality professionals


    REQUIREMENTS
    Minimum of 15 years experience in Biotech Quality Assurance & CMC
    Bachelor's degree in a science discipline
    Recent exposure to Cell & Gene therapy, CRISPR and/or Genomics
    In-depth knowledge of global regulations governing cell and gene therapy products
    Strong leadership and communication skills

    ABOUT i-PHARM CONSULTING
    i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac.

    We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs).

    i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

    www.i-


    TO APPLY

    If you would like to discuss this vacancy further, please call Principal Consultant David Fearnley on , or email - If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


    KEY WORDS
    Quality Assurance / Head of QA / Quality Assurance Director / Genomics / Drug Discovery / CRISPR / Immuno-Oncology / Therapeutics / Qualification / SOP / Quality / QA / ISO / ISO 9001 / GMP / QSR / product life cycle / full life cycle / GLP / Good Manufacturing Practice / Biologics / QMS / Cell & Gene

    Desired Skills and Experience

    Minimum of 15 years experience in Biotech Quality Assurance & CMC
    Bachelor's degree in a science discipline
    Recent exposure to Cell & Gene therapy, CRISPR and/or Genomics
    In-depth knowledge of global regulations governing cell and gene therapy products
    Strong leadership and communication skills
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