Monique L. Sprueill, PMP

Johnson & Johnson
Senior Manager, Strategy, Insights & Innovation
Monique Sprueill, PMP is a Senior Manager, Strategy, Insights and Innovation at Johnson & Johnson with over 15 years of experience in the Pharmaceutical, Biotechnology, and Consumer Healthcare industries. She has managed projects that focused on life-cycle documentation development, capital project planning, validation, equipment qualification, product changeover and process improvements for manufacturing and packaging sites. She has negotiated Quality Agreements with Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) in support of supply and business continuity and product launches. She has conducted facility audits to assess technical capabilities, identify potential gaps in quality systems, and review GMP practices. She has also led multifunctional teams in conducting Risk and Impact Assessments and Failure Mode and Effects Analysis (FMEA). Prior to joining Ernst and Young, Monique's career included positions at Novartis, Bristol Myers-Squibb and Sanofi. Her areas of expertise include process engineering, managing supplier quality relationships, product launches, automated manufacturing and packaging systems, change management and validation. She is passionate about developing trust, collaborating to find the “best” solutions to resolve short term issues and building a strategic and tactical foundation to accomplish long term goals. She currently serves on the ISPE NJ Board of Directors and has been an active member of ISPE since 2001. She holds a B.S. in Chemical Engineering and M.S. in Engineering Management from New Jersey Institute of Technology (NJIT). Currently serving as ISPE New Jersey Chapter Secretary.