EXECUTIVE GXP QUALITY ADVISORY FOR BIOTECH & PHARMA
Executive GxP Quality Leadership
for Growing Biotech & Pharma
Helping biotech and pharmaceutical companies build, remediate, and scale phase-appropriate quality systems, strengthen outsourced operations, and prepare for regulatory inspections and critical development milestones.
25+ years of Quality Assurance and Quality Control experience
Experience across early-stage development through late-stage and commercial readiness
Executive Quality leadership across virtual and outsourced operating models
Practical, risk-based approach to compliance and quality systems
Quality Systems. Inspection Readiness. Sponsor Oversight.
OUR FOCUS
DB GxP Quality Advisors provides senior-level quality and compliance advisory support to biotech and pharmaceutical organizations. We help companies design, remediate, and scale quality systems that are fit-for-purpose, inspection-ready, and aligned with development stage and regulatory expectations.
Phase-appropriate Quality infrastructure that grows with the organization.
Build & Scale
Quality system remediation, inspection readiness, CAPA, and compliance improvement.
Remediate & Prepare
Fractional or project-based Quality leadership for organizations needing experienced executive support.
Lead & Advise
GxP Quality Advisory Services
OUR SERVICES
Structured to meet the needs of emerging and established organizations, our services provide senior-level quality expertise across systems, oversight, readiness, and operational execution.
Quality Management Systems
Design, implementation, remediation, and scaling of phase-appropriate Quality Management Systems aligned with development stage and regulatory expectations.
Quality system remediation, inspection readiness, CAPA, and compliance improvement.
Remediate & Prepare
Risk-based oversight models for CROs, CMOs, CDMOs, laboratories, and other critical GxP service providers.
Vendor & Sponsor Oversight
SOP & Governance Development
Authoring and refining governance documents, procedures, quality plans, and operational quality frameworks.
Quality advisory services spanning clinical development, CMC oversight, technology and process transfer, and Quality operations.
Clinical & CMC Quality Support
Senior-level Quality leadership for companies needing strategic expertise without a full-time executive hire.
Fractional Quality Leadership
Phase-appropriate quality system design and remediation
Support across clinical, CMC, vendor, and quality governance functions
Risk-based compliance strategies aligned with operational realities
Senior Quality Expertise Tailored to the Realities of Modern Biotech
Whether your organization needs strategic quality leadership, SOP and governance support, or a stronger sponsor oversight model, DB GxP Quality Advisors provides focused, executive-level support aligned to your stage, risks, and operational structure.
WHY DB GXP QUALITY ADVISORS
Executive-level consulting with hands-on practical support
Experience supporting virtual and outsourced operating models
ABOUT DB GXP QUALITY ADVISORS
About Dave Braggs
Dave Braggs is a seasoned Quality executive with more than 25 years of experience across GxP functions and early-stage through late-stage pharmaceutical and biotechnology development. He has extensive expertise in building and scaling phase-appropriate Quality Management Systems, inspection readiness, and oversight of outsourced manufacturing and clinical operations.
Dave most recently served as Vice President of Quality Assurance at Kezar Life Sciences, where he led GxP Quality strategy across clinical development, CMC, and a global network of outsourced manufacturing, laboratory, and clinical service providers.
Prior to Kezar, Dave served as Director of Quality System Improvements at ViaCyte, Inc., where he led the development and implementation of phase-appropriate GxP Quality Systems. He also held the role of Director of Quality at Tanvex BioPharma, where he was responsible for Quality Operations, Systems, and Compliance.
Earlier in his career, Dave held senior Quality leadership roles including Executive Director of Quality at Vital Therapies, Inc. and Associate Director of Quality Assurance/Compliance at Ionis Pharmaceuticals.
Dave holds an M.A. and M.B.A. from Webster University and a B.S. in Biology from the University of New Mexico
Quality Systems. Inspection Readiness. Sponsor Oversight.
OUR APPROACH
The right quality framework should support execution, strengthen oversight, and fit the stage of the organization. DB GxP Quality Advisors helps organizations build practical, sustainable quality systems that support compliance while enabling business operations.
Remediate & Prepare
Quality system remediation, inspection readiness, CAPA, and compliance improvement.
Phase-appropriate Quality infrastructure that grows with the organization.
Build & Scale
Fractional or project-based Quality leadership for organizations needing experienced executive support.
