Jonathan P.

About Jonathan P.

I am a global Chief Quality Officer with more than 30 years of leadership experience across biologics, small molecules, combination products, and advanced therapies including cell and gene therapy within multinational pharmaceutical organizations. My background includes leadership roles in both Quality Assurance and manufacturing operations, providing a practical perspective across development through commercialization while maintaining regulatory confidence and reliable patient supply.In my role, I oversee worldwide strategy across internal manufacturing networks and external partners including CMOs and CROs. I work closely with executive leadership and global health authorities to ensure performance aligns with enterprise risk, operational continuity, and business growth.My experience spans the full product lifecycle and multiple therapeutic areas including oncology, nephrology, immunology, and CNS. I have led organizations through inspections, expansion, and operational change by strengthening inspection readiness, establishing governance frameworks, and advancing culture across global operations.As a Chief Quality Officer, I view the organization as a business partner that translates risk into informed decisions enabling innovation while protecting patients and company reputation.ASQ Certified Quality Auditor and Six Sigma Green Belt.

Experience

1. Chief Quality Officer (EVP), Global Head of Quality Assurance

   Kyowa Kirin Co., Ltd.

   Feb 2019 — Present · Princeton, NJ, US

   Kyowa Kirin is a global biopharmaceutical company headquartered in Japan with development and commercial operations across the United States, Europe, and Asia focused on oncology, nephrology, immunology, and CNS therapies.I lead the global Quality organization supporting development through commercialization across internal manufacturing sites and a worldwide network of CMOs and CROs. In this role, I established enterprise quality governance aligning R&D, Technical Operations, and commercial manufacturing under unified global GxP standards and implemented a global quality strategy and performance framework across multi regional operations. I support programs spanning biologics, small molecules, nucleic acid therapies, and advanced modalities including cell and gene therapy, and I built an inspection readiness and regulatory engagement model supporting worldwide health authority interactions. My work has focused on integrating risk based quality management and standardizing quality systems across internal sites and external partners to strengthen compliance and ensure reliable patient supply.I partner with executive leadership to ensure quality performance supports business growth, regulatory confidence, and operational continuit

Education

• Temple University

  MBA, Business Administration

  1998 — 2001

• Penn State University

  BS, Environmental Resource Management

  1991 — 1995