Cynthia N. Brysch

About Cynthia N. Brysch

Award-winning, internationally recognized, and certified QA/RA executive, consultant, and accomplished biotechnologist with 20+ years of experience shaping process and product strategies across pharmaceuticals, medical devices, and biopharmaceuticals.With a proven track record supporting 500+ sponsor programs worldwide, I deliver risk-based strategies that optimize quality, compliance, and program management—resolving today’s challenges while proactively preventing tomorrow’s.As a keynote speaker, trainer, and industry leader, I bring deep expertise in GxP regulations (GLP, GCLP, GCP, GMP), ISO, and ICH standards. I spearhead advances in AI-enabled clinical trials, ensuring regulatory compliance, data integrity, and quality across pharma, biotech, and MedTech. From discovery through inspection readiness and market authorization, I bridge innovation with compliance to drive sustainable product success.Specialties:AI in Clinical Trials | Biopharmaceuticals | Pharmaceuticals | Medical Devices (Class In-Vitro Diagnostics (IVD)| Combination Products (CDx)| Cell & Gene Therapy | QA/RA | Programmatic Lifecycle Development & Management | Quality Management Systems (QMS)| Risk Management | Clinical Trials (Phase I–IV)| Post-Market Surveillance | Regulatory Submissions (IND, IDE, NDA, ANDA, BLA, PMA, De Novo, 510(k))| Rare Diseases | Validation | CAPA | Quality by Design (QbD)| Audits | Inspection Readiness | Accreditation (ISO 13485:2016, ISO 9001:2015, CAP/CLIA)| Training & Continuous Improvement

Experience

1. Vice President of Quality Assurance and Regulatory Affairs

   Devine Guidance International, Inc

   Sep 2024 — Present

   Executive leader specializing in the development, integration, and execution of quality and regulatory strategies for medical device, pharmaceutical, and combination product clients. As VP & COO, I drive the operational backbone of a dynamic life sciences consulting firm—overseeing corporate infrastructure, client program management, quality assurance and regulatory compliance delivery across global markets.I lead cross-functional teams that implement and remediate Quality Management Systems (QMS) to ISO, GxP and ICH guidelines, ensuring readiness for both FDA and international inspections, notified body audits, and product approvals. With a strategic focus on operational scalability and regulatory rigor, I align consulting operations with evolving client needs, from early-phase development through post-market support.Core leadership areas:• Quality systems design, remediation, and harmonization across global sites• Regulatory affairs strategy including premarket submissions, CE marking, and FDA correspondence• Operational development and business infrastructure to support sustained growth and compliance• End-to-end client program oversight, from QMS implementation to regulatory filings and market entryI bring a solutions-oriented mindset to complex regulatory environments, guiding clients through transformation, compliance, and commercialization with speed, clarity, and confidence.

Education

• Liberty University

  Doctor of Philosophy - PhD, Health Services/Allied Health/Health Sciences, General

• Oklahoma State University

  Biochemistry and Molecular Biology

  2006 — 2008

• University of Houston

  Bachelor of Science (B.Sc.), Biotechnology

  2009 — 2012

Skills

• Mass Spectrometry
• Problem Solving
• Clinical Pharmacology
• Gel Electrophoresis
• Spectrophotometry
• Fluorescence Microscopy
• Polymer Composites
• Hplc
• Communication
• Pro Engineer
• Materials Science
• Standards Development
• Standards Compliance
• Lims
• Sds-Page
• Biological Systems
• Regulatory Affairs
• Purification
• Protein Expression
• Flow Cytometry
• Analytical Chemistry
• Sintering
• Microbiology
• Computer Proficiency
• Bioinformatics
• Management
• Team Building
• Quality Assurance
• Protein Chemistry
• Biotechnology
• Protein Purification
• Stem Cells
• Biomaterials
• Polymer Nanocomposites
• Column Chromatography
• Laboratory
• Chromatography
• Dna Sequencing
• Gas Chromatography
• Cad