Michael Grischeau is the Director of Data Analytics and Management Review at AbbVie. He is the current co-chair of the Management Responsibilities sub-committee for ISPE's Advancing Pharmaceutical Quality program.
Michael has over 20 years in the Pharmaceutical and Medical Device industry. His professional experience includes ownership of Management Review processes and global analytics teams that provide strategic insights on quality system health, product data, and site performance across global manufacturing networks. He is currently leading the ongoing redesign of AbbVie's quality management approach to data analytics, incorporating a modernized set of metrics for quality systems and compliance. He is driving automation of processes to ensure they are efficient, easily accessible, and user friendly to enable high impact, cross functional decision making along AbbVie’s product value chain.
The ISPE Advancing Pharmaceutical Quality (APQ) program team has been actively engaged with the US Food and Drug Administration’s (US FDA) Quality Management Maturity (QMM) program since its inception and along the...
The ISPE 2023 Annual Meeting & Expo agenda is always packed with sessions offering pharmaceutical professionals opportunities to engage in industry-critical conversations. Several of ISPE's regulatory initiatives took center stage during the technical sessions in the Regulatory and Quality track at the
Competitive advantage and sustained business results depend on leaders building and maintaining a strong culture. This has been reinforced by the increased challenges in attracting and retaining talent. The FDA is also placing significant focus on Quality Management Maturity. But how do leaders know if they are on track? Assessing leadership systems is often overlooked or much more difficult...