Jay Barnhill

About Jay Barnhill

WHAT I DO:I strategically partner with FDA-regulated life sciences companies to help them pass inspections and reduce compliance risk through cGMP consulting, quality system remediation, and deviation backlog reduction.WHAT MAKES ME UNIQUE:With over 30 years in FDA-regulated industries, I bring hands-on experience and a strategic, systems-based approach. I don’t just advise — I work side-by-side with clients to implement sustainable, compliant solutions that build long-term quality capability.SERVICES I PROVIDE:• Deviation Management & Backlog Reduction• CAPA & Root Cause Coaching• FDA Inspection Readiness• Quality System Remediation• Data Integrity Remediation• Person-in-Plant (PIP) Quality Oversight• Coaching, Mentoring, & TrainingPROBLEMS I SOLVE FOR CLIENTS:• Backlogged deviations and ineffective investigations• Teams that are undertrained or unsure how to respond to regulatory expectations• Outdated or failing quality systems• Data integrity risks and poor documentation practices• Lack of QA accountability and a fragmented quality cultureBENEFITS MY CLIENTS REALIZE:• Passed FDA inspections with confidence• Compliant, faster deviation closures• Robust, inspection-ready quality systems• Reduced regulatory risk and enforcement exposure• Stronger QA teams and sustainable quality cultureWHO I WORK WITH:• FDA-regulated life sciences organizations across the U.S, LATAM, EU, India, and Asia• Startups, scale-ups, CDMOs, and global manufacturers• Quality leaders seeking strategic compliance supportINDUSTRIES I WORK WITH:• Pharmaceuticals • Biotech • Vaccines• Cell & Gene Therapy • CDMOs/CMOs• LaboratoriesWHAT CLIENTS SAY:“Jay doesn’t just consult — he rebuilds the system and mentors the team.”“Deviation backlog down 70% in 90 days — and we passed FDA inspection.”“He explained root cause analysis in a way that stuck.”“His input elevated the quality and defensibility of our lab documentation.” J••••••••@AltabrisaGroup.com +19•••••••00

Experience

1. Quality Consultant

   Coherus Oncology

   Aug 2015 — Present · Redwood City, CA, US

   For the past eight years, I have been privileged to serve as a Quality Consultant at Barnhill Associates, right in the heart of Redwood City, CA. My tenure here has been marked by continuous learning, collaboration, and fostering a culture of quality across various industries. Spearheaded the development and implementation of customized quality management systems for diverse clients. Positioned in the technological nerve-center of Redwood City, enhancing my exposure to various cutting-edge industries. Collaborated effectively with multifunctional teams to seamlessly integrate quality standards across business operations. Conducted comprehensive training modules, emphasizing best practices in quality, to instill a proactive mindset of continuous improvement. Delved deep into performance metrics, employing data-driven strategies to pinpoint areas ripe for enhancement. Successfully guided numerous businesses in their quest for certifications by ensuring unwavering adherence to industry and regulatory benchmarks. Innovatively streamlined business operations, integrating the latest in quality tools and methodologies. Offered seasoned counsel on risk management, drawing up robust mitigation strategies to preempt and counter potential challenges. Maintained a consistent client-centric approach, fostering relationships built on trust, understanding, and tailored solution delivery. Acted as a pivotal change agent, often challenging the status quo, to usher in best-in-class quality processes and frameworks.

Education

• Barton College

  Bachelor’s Degree, Cell Biology

  1992

• Barton College

  B.A., Chemistry, December 1992 (Equivalent Hours Completed)

• Barton College

  B.S., Cell Biology, December 1992

Skills

• Deviation Management
• Dissolution
• Compliance
• Technical Transfers
• Technical Writing
• Analytical Chemistry
• Gdp
• Vaccines
• Consulting
• Failure Analysis
• Investigation
• Customer Service
• Audit
• Hplc
• Pharmaceutical Manufacturing
• Process Improvement
• Cleaning Validation
• Biologics
• Medical Devices
• Change Control
• Chromatography
• Quality System Compliance
• Glp
• Strategic Planning
• Gmp
• Parenteral
• Process Validation
• Trackwise
• Lean Thinking
• Batch Record
• Pharmaceutical Microbiology
• Quality Assurance
• Software Documentation
• Root Cause Analysis
• Root Cause Problem Solving
• Fishbone
• Pharmaceutical Sciences
• Laboratory
• Lims
• Pharmaceutical Packaging