Michael Nuzzolo

Site Quality Head, Exec. Director QA at Genentech (A Member of the Roche Group)

Role
Site Quality Head, Exec Director Qa at Genentech
Location
Philadelphia, PA, US
LinkedIn followers
500 followers

About Michael Nuzzolo

Site Quality Head with over 30 years of quality-related experience in commercial manufacturing of vaccine, pharmaceutical, biotech and gene therapy products. Extensive knowledge and experience in quality control testing, analytical method transfer, analytical method validation, regulatory compliance, product release, and other quality systems.

Experience

  1. Site Quality Head, Exec Director Qa

    Genentech

    Jun 2025 — Present · Philadelphia, PA, US

    Provide leadership for strategic site initiatives, ensuring continuous compliance with all applicable internal and external regulations, standards, policies and procedures related to the quality, regulatory status, and performance of Company operations, processes and products. • Responsible for the oversight of product release for bulk drug substance, drug product and packaged material for clinical and commercial use, validation, regulatory inspection readiness, supplier change notification, training, analytical data review and data integrity while maintaining an in-depth understanding of ATMP’s, GMP’s, GCP’s and GLP’s.

Education

  • La Salle University

    Bachelor of Arts - BA, Biology/Biological Sciences, General

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Michael Nuzzolo — Site Quality Head, Exec Director Qa at Genentech in Philadelphia, PA, US | Unifers