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    Vice President Quality Assurance - New Jersey, United States - Skills Alliance

    Skills Alliance
    Skills Alliance New Jersey, United States

    1 week ago

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    Description

    I am exclusively partnered with a client looking to recruit the most senior memeber of their QA team. This is a critical role. I am looking to speak with individuals experienced in biologics - particularly antibodies.

    Responsibilities:

    • Oversee and manage the quality assurance department, ensuring compliance with all applicable regulations and guidelines, such as cGMP, ICH, and FDA requirements.
    • Develop, implement, and maintain robust quality management systems, including quality control procedures, process validation, and continuous improvement initiatives.
    • Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs) to ensure the quality and consistency of biologics throughout the product lifecycle.
    • Establish and monitor key quality metrics, identify areas for improvement, and implement corrective and preventive actions.
    • Provide strategic guidance and leadership in quality-related decision-making, risk management, and quality culture development.

    Experience:

    • Minimum of 10 years of progressive experience in quality assurance, preferably in the biopharmaceutical or biologics industry.
    • Demonstrated expertise in the design, implementation, and management of quality systems for the development, manufacturing, and release of biological products.
    • In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of biologics, including FDA, cGMP, and ICH requirements.
    • Proven track record of leading and managing a quality assurance team, with a strong focus on continuous improvement and fostering a culture of quality.
    • Advanced degree (e.g., MS, PhD) in a relevant scientific or engineering field, or equivalent combination of education and industry experience.
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