Emmanuel Uche

About Emmanuel Uche

With over 20 years of quality experience in the pharmaceutical and biotechnology industry, I am a seasoned quality leader and a certified quality auditor and manager by ASQ. I have a passion for ensuring quality compliance across all aspects of operations, from internal and external audits, to regulatory correspondence, to quality management systems and continuous improvement.Currently, as the Associate Director of Quality Compliance at Kite Pharma, I am responsible for leading the Corporate Internal Quality Audit group and provide guidance and support to ensure compliance with global quality standards and regulatory requirements worldwide. I also create awareness of emerging regulatory trends throughout the organization. I work with cross-functional teams and stakeholders to facilitate effective communication and collaboration on quality issues and initiatives. My goal is to drive quality excellence and compliance across the organization and enable the delivery of innovative and life-saving therapies.

Experience

1. Associate Director, Quality Assurance and Compliance

   Kite Pharma

   May 2023 — Present · Santa Monica, CA, US

   Responsible for GMP compliance across Kite Operations leading all aspects of the corporate internal quality audit group. Ensure sites and functional teams operate in compliance with global quality standards and regulatory requirements. Lead in creating awareness of emerging regulatory trends throughout the organization and all regulatory correspondence. Provide guidance as necessary to ensure compliance with relevant regulations and requirements worldwide and represent all Technical Operations at the Kite Corporate Compliance Committee.Develop and implement the comprehensive global audit plan for all external vendors, suppliers, affiliates, and internal functions. Develop internal operations audit plan based on risk considerations and oversee execution of internal audits. Ensure that Quality Compliance personnel are qualified and trained to perform assigned functions in accordance with regulatory requirements and that all auditors both internal and contract are competent.Review all quality policies and global SOPs to assure compliance to regulatory filings as well as global regulations and guidance. Assure that audit systems, CAPAs and computerized quality systems are managed effectively, and all compliance risks are reported effectively through the Metric Control Plans and Quality Management Review.

Education

• California State University - East Bay

  Bachelor of Science - BS, Biology, General

• Feather River Community College District

  Associate of Science - AS, Biology, General

• Seton Hall University School of Law

  Masters Jurisprudence - MJ, Pharmaceutical/Medical Device Law and Compliance

• Southern New Hampshire University

  Bachelor of Arts - BA, General Studies, Business Information Systems

• Southern New Hampshire University

  Master of Business Administration - MBA, Business Administration and Management