Brian Duncan

About Brian Duncan

Proven leader experienced in global quality and operations risk identification and risk monitoring, regulatory response and strategic communications planning, site-wide/ multi-site remediation planning and execution, site inspection planning and readiness execution, translating global network standards into local quality systems from the ground up, and driving transformative culture change. Extensive expertise in site regulatory remediation, regulatory approval of international sites, product technology transfer/launch and project management including current regulatory expectations for process qualification and lifecycle management.

Experience

1. Chief Operating Officer

   Quality Executive Partners, Inc. Qxp

   Jan 2020 — Present

   QxP is a management consulting and technology firm, providing the life sciences industry with tomorrow’s innovative solutions, tailored to meet the most daunting technical challenges of today. We are scientific thought leaders, with decades of experience as executive leaders within global pharmaceutical firms and as trusted consulting partners to these firms. The mission of QxP is to ensure our clients meet their business, quality, and compliance goals simultaneously. We achieve this through a unique partnering relationship that provides technical expertise, educational tools, mentoring and execution support. Our success is defined by providing timely delivery of those goals coupled with the transfer of knowledge and capability to the client’s team.

Education

• The University of Texas at San Antonio

  Bachelor's, Chemistry

  1996 — 1997

Skills

• Validation
• Cleaning Validation
• 21 Cfr Part 11
• Quality Assurance
• Pharmaceutics
• Quality Control
• Gmp
• Hplc
• Drug Development
• Quality Management
• Biopharmaceuticals
• Gxp
• Quality Auditing
• Change Control
• Regulatory Submissions
• Analytical Chemistry
• Biotechnology
• Technology Transfer
• Computer System Validation
• Pharmaceutical Industry
• Sop
• Fda
• Lims
• Quality System
• V&V
• Chromatography
• Glp
• Regulatory Affairs
• Lifesciences
• Capa
• Regulatory Requirements