Six-plus years ensuring FDA cGMP compliance and quality-system integrity across pharmaceutical and biotech operations — from batch-record review and material dispositions to SOP authoring, audits, and root-cause investigations.
Quality systems, regulatory compliance, and the documentation discipline that keeps regulated manufacturing audit-ready.
Building and maintaining the cGMP quality framework — deviations, CAPA, and change control that hold up under inspection.
Keeping manufacturing and lab operations aligned to FDA cGMP and internal standards, and ready for audit at any time.
Reviewing batch records and analytical data, authoring SOPs, and disposing material — accurate, traceable, defensible.
Running quality workflows and material dispositions in the LIMS and ERP platforms regulated manufacturers rely on.
Leading cross-functional investigations and root-cause analysis to resolve quality issues and tighten operations.
Across pharmaceutical and biotech manufacturing, clinical research coordination, and medical-record review.
Six-plus years across pharmaceutical, biotech, clinical research, and medical review. Reverse chronological.
A practical, documentation-first approach to keeping regulated operations compliant and audit-ready.
Batch records, SOPs, and analytical data reviewed for accuracy and traceability — so the record speaks for itself in an audit.
FDA cGMP and internal standards built into day-to-day operations, not bolted on — material released only when it meets spec.
Cross-functional investigations that find the real cause and close it out, improving process efficiency along the way.
Open to Quality Assurance and compliance roles in pharmaceutical and biotech. Email or LinkedIn gets a reply.
Hiring for a QA, quality-systems, or compliance role? I'd be glad to talk — no form required.
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