Keith Brown

VP Quality - Sterile Products (Human & Animal Health) | Multi‑Site Leadership | CDMO Oversight | Global Compliance

Role
Vice President of Quality at American Regent, Inc.
Location
Columbus, OH, US
LinkedIn followers
500 followers
General Business & ManagementView LinkedIn profile

About Keith Brown

Quality Assurance professional with experience in diverse technologies; Sterile Parenteral, Vaccines, Oral Solid Dose, API, liquid suspensions. Record of producing timely, cost-effective, quality results compliant with all applicable regulations in complex environments. Recognized for ability to effectively communicate with leaders and managers, cross functional professional staff and suppliers. Quality roles include: Quality Systems, General Management, Regulatory Compliance, Contract Manufacturing, Team Building and Leadership, Continuous Process Improvement, Change Management, Staff Development & Training.

Experience

  1. Vice President of Quality

    American Regent, Inc.

    Nov 2024 — Present · New Albany, OH, US

    Seasoned quality executive with extensive experience leading global quality operations across sterile product manufacturing for both human and animal health. Proven track record of establishing and maintaining robust quality systems across multiple manufacturing sites, ensuring compliance with international regulatory standards. Skilled in oversight of Contract Development and Manufacturing Organizations (CDMOs), driving alignment with corporate quality expectations, and safeguarding product integrity from development through commercial supply. Recognized for strategic leadership, cross-functional collaboration, and fostering a culture of continuous improvement to deliver safe, effective, and compliant products worldwide.

Education

  • Indiana University Indianapolis

    BS/BA, Biology/Chemistry

    1990 — 1996

  • University of Phoenix

    MBA, Business

    2002 — 2005

Skills

  • Lean Manufacturing
  • Capa
  • Project Management
  • Cleaning Validation
  • U.s. Food and Drug Administration (Fda)
  • Six Sigma
  • Gxp
  • Continuous Improvement
  • Quality Auditing
  • Aseptic Processing
  • Training
  • Change Control
  • Regulatory Affairs
  • Quality System
  • Glp
  • Corrective and Preventive Action (Capa)
  • Biotechnology
  • Lims
  • Change Management
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Cross-Functional Team Leadership
  • Regulatory Submissions
  • Leadership
  • Technology Transfer
  • Management
  • Computer System Validation
  • Quality Assurance
  • Standard Operating Procedure (Sop)
  • Quality Control
  • Gmp

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Keith Brown — Vice President of Quality at American Regent, Inc. in Columbus, OH, US | Unifers