Blake Jensen

About Blake Jensen

I am a senior Quality and Compliance leader with over 20 years of experience building, scaling, and leading enterprise GxP quality systems across clinical development and regulated environments. I partner with organizations to establish inspection-ready operations, strengthen regulatory compliance, and embed quality as a strategic driver of business success.As a Fractional Head of Quality and GxP Consultant, I have led end-to-end Quality Assurance functions across GCP, GMP, GLP, and GVP, supporting clinical-stage and growth-phase organizations, CROs, CDMOs, and clinical service providers. My work spans QMS design and implementation, audit and vendor oversight, inspection readiness, deviation and CAPA management, and executive-level quality governance.I have successfully designed and implemented scalable Quality Management Systems aligned with FDA, ICH, and global regulatory standards, reducing audit findings, closing compliance gaps, and improving inspection outcomes. I regularly lead risk-based audits and regulatory inspections, oversee vendor qualification programs, and deliver actionable quality insights to senior leadership teams and Boards of Directors.Known for a pragmatic, risk-based approach, I help organizations balance regulatory rigor with operational efficiency, accelerating development timelines while maintaining full compliance. I have supported critical regulatory milestones, including FDA inspections, NDA approvals, Emergency Use Authorizations, and priority regulatory pathways.My focus is on building sustainable quality systems, strengthening governance, and enabling organizations to move forward with confidence in highly regulated environments.

Experience

1. Founder, Principal Consultant

   B3 Quality Consulting, Llc

   Nov 2023 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Lead fractional Quality and Clinical QA functions for emerging biotech companies, CROs, and clinical service providers, supporting multiple organizations simultaneously while driving compliance and operational excellence.Design and implement scalable GxP Quality Management Systems (QMS) aligned with FDA, ICH, and global regulatory requirements, improving inspection readiness and reducing compliance risk by up to 30%.Provide enterprise-level quality governance, delivering executive-ready reporting and actionable insights to senior leadership teams and Boards of Directors to strengthen oversight and strategic decision-making.Execute risk-based audits and regulatory inspections across CROs, CDMOs, pharmacovigilance vendors, and investigator sites, identifying gaps and leading corrective and preventive actions to maintain 100% regulatory compliance.Develop and operationalize vendor qualification frameworks and QMS gap assessments, improving supplier quality performance and streamlining inspection readiness across clinical and manufacturing operations.

Education

• University of Utah

  Bachelor's degree, Biology / Chemistry

• University of Utah

  BS, Biology/Chemistry

  1997 — 2002

• University of North Carolina Wilmington

  Master of Business Administration (M.B.A.)

  2015 — 2017

Skills

• Gcp
• CRO
• Regulatory Affairs
• Pharmaceutical Industry
• Clinical Trials
• Fda
• Quality Assurance
• Governance
• Risk Management
• 21 Cfr Part 11
• Clinical Development
• Edc
• Clinical Research
• Ctms
• Validation
• Quality Management
• Oncology
• Ich-Gcp
• Biotechnology
• Clinical Monitoring
• Drug Development
• Glp
• Pharmacovigilance
• Lifesciences
• Regulatory Requirements
• Clinical Data Management
• V&V
• Change Control
• Vaccines
• Biopharmaceuticals
• Capa
• Gmp
• Life Sciences
• Clinical Trial Management System (Ctms)
• U.s. Title 21 Cfr Part 11 Regulation
• CRO Management
• Good Clinical Practice (Gcp)
• U.s. Food and Drug Administration (Fda)
• Electronic Data Capture (Edc)