Adrienne Xenos-Koehler

Quality Assurance leader with extensive experience supporting nonclinical development, regulatory submissions, and enterprise-critical initiatives across global pharmaceutical and biotechnology organizations. I bring deep expertise in GxP compliance, quality systems, data integrity, and risk management, with a strong track record of partnering cross-functionally to ensure regulatory alignment and inspection readiness. Currently serving in an Associate Director–level Quality Assurance role, I provide strategic QA leadership across nonclinical IND-enabling activities, CRO and vendor oversight, and M&A integration efforts. My experience includes direct quality oversight of pharmacology, DMPK, and toxicology studies, contribution to multiple IND submissions, and review of CTD modules, Investigator’s Brochures, and Health Authority correspondence. I am recognized for proactively integrating quality into study design, execution, data review, and reporting to safeguard data integrity and alignment with global regulatory expectations (FDA, ICH, EMEA). I have led risk-based audits, deviation investigations, CAPA oversight, and quality issue remediation, while maintaining strong partnerships with scientific, regulatory, and business stakeholders. With a background spanning discovery research through nonclinical safety and enterprise QA, I bring a pragmatic, science-informed approach to quality leadership. I am particularly experienced in CRO oversight, vendor qualification, data governance (ALCOA+, 21 CFR Part 11), and supporting complex initiatives such as IND readiness and post-acquisition integration.