Dave McNally

Background

About Dave McNally

With over two decades of experience in the pharmaceutical and medical device industries, I have honed my skills in Technical Services, Validation, and Quality Engineering. My journey is driven by a passion for excellence and a commitment to ensuring top-tier quality and regulatory compliance. My career is marked by transformative leadership and strategic vision. I have successfully spearheaded major projects, including overhauling the External Quality Site Quality Review Team (SQRT), eliminating quality records backlogs and reducing major deviations. This achievement not only streamlined operations but also set a new standard for efficiency. At the helm of validation oversight, I managed a $18 million Drug Substance Tech Transfer to a CMO, ensuring seamless execution and adherence to stringent quality standards. As Director of Strategy & Business Operations for Global Quality, I developed long-term strategies that aligned with corporate goals and managed an annual budget exceeding $1 million. My initiatives in quality network strategy, value realisation, and cycle time reduction have driven continuous organisational improvement. My forte is leading teams to success. I have directed Quality Assurance oversight for pre-commercial products, guiding them from toxicological studies to Investigational New Drug (IND) filing. My expertise extends to shipping validation for biologics, small molecules, gene therapy, and combination device products, ensuring compliance with global standards. Among my proudest accomplishments is being honoured with the BioMarin Technical Operations (TOPs) Top Talent award, recognising my exceptional contributions to the organisation. My technical skills include equipment qualification (IQ/OQ/PQ), process validation (PV), Lean/Six Sigma methodologies, and quality risk management. I am passionate about driving innovation and leading high-performing Technical Services, Validation, and Quality Engineering teams. My goal is to exceed quality and regulatory standards, ultimately improving patient outcomes and advancing industry standards. Let's connect and explore opportunities for collaboration and excellence.