GxP Global Quality Network is a boutique GxP consulting firm led by Monica Brooks, MSc, delivering senior-level pharmaceutical auditing, regulatory affairs, and quality assurance expertise to organizations nationwide.
GxP Global Quality Network exists to help pharmaceutical, biotech, and life science organizations achieve and sustain the highest standards of regulatory compliance, protecting patients, products, and organizations.
Monica Brooks has been working in pharmaceutical quality and life sciences since 1996, with 20+ years dedicated specifically to GxP auditing across GCP, GLP, GCLP, and GVP disciplines. Her career includes a senior tenure at Janssen Pharmaceutical Research & Development before transitioning to independent senior consulting through GS Global Quality.
Monica's audit experience spans investigator site audits, vendor qualification, internal process audits, TMF audits, mock FDA BIMO inspections, and pre-approval inspection readiness across studies regulated by FDA, EMA, MHRA, and Health Canada. She has specialized expertise in inspection readiness, FDA BIMO preparation, and TMF remediation, with active engagements across oncology, gene and cell therapy, rare disease, vaccines, and metabolic disease programs.
When you engage GxP Global Quality Network, the senior auditor who scopes the engagement is the senior auditor who conducts the audit and writes the report. No junior CRA handoffs. No team rotation. No diluted expertise. Each engagement is led by a quality professional with 20+ years of cross-functional GxP experience.
Our network model means we can scale to multi-site programs and parallel audit streams while preserving the depth and continuity sponsors expect from boutique consulting. Network auditors are vetted for senior credentials, regulatory currency, and audit experience across GCP, GLP, GCLP, and GVP disciplines.