Mike Renick

Background

About Mike Renick

As a seasoned leader in Computer System Validation (CSV) within the biotech, pharmaceutical, and medical device sectors, I bring over two decades of experience driving compliance and quality for GxP-regulated software systems. With 15 years at a Senior level, I’ve developed and executed robust CSV and Computer Software Assurance (CSA) frameworks that align with industry-leading standards and support rapid innovation. At the heart of my approach is a strategic vision: Policy & Process Leadership – Designed and rolled out CSV policies and validation strategies that ensure scalability, consistency, and regulatory compliance. Cross‑Functional Collaboration – Worked closely with IT, software engineering, regulatory affairs, and operations to seamlessly embed validated systems into business processes across the SDLC. Risk-Based Oversight – Led risk assessments, FMEAs, root cause investigations, and CAPA programs to proactively mitigate validation and data-integrity risks. Technology Enablement – Oversaw validation of cloud-based systems, electronic records management, and data-integrity solutions; spearheaded vendor audits and validation tool selection. Audit & Readiness – Directed audit-readiness programs, ensuring inspection readiness across internal teams, vendors, and systems. Leadership & Culture – Built and inspired high-performing CSV QA and IT teams, fostering collaborative environments. Advanced knowledge of risk management frameworks and CSA best practices. With a growth mindset and strong executive presence, I advise leadership on quality and compliance strategies, and ensure systems validation supports business agility.