John Maiero
About John Maiero
John Maiero is the Director of Quality Compliance at Bristol Myers Squibb in Summit, New Jersey, with over 20 years of experience in pharmaceutical manufacturing and quality management.
Current Position at Bristol Myers Squibb
John Maiero serves as the Director of Quality Compliance at Bristol Myers Squibb in Summit, New Jersey, United States. In his role, he oversees compliance initiatives and ensures that the company adheres to quality standards within pharmaceutical manufacturing. His responsibilities likely include managing risk assessments, investigating compliance issues, and implementing continuous improvement strategies to maintain and enhance quality control processes.
Previous Roles at American Regent, Inc.
Before joining Bristol Myers Squibb, John Maiero had a substantial career at American Regent, Inc. in Shirley, New York. He served in multiple capacities, starting as Supervisor of Quality Assurance in 2004, then gradually advancing to Sr. Manager and eventually Director of Quality Assurance. During his tenure, he handled roles such as Director and Head of Quality Assurance, Director of Quality Compliance, and Associate Director of Quality and Regulatory Compliance. His assignments likely included overseeing quality audits, establishing risk management protocols, and liaising with regulatory bodies.
Education and Expertise at SUNY Empire State College
John Maiero completed his Bachelor of Science in Business, Management & Economics from SUNY Empire State College between 2002 and 2006. This education provided a foundation in business principles, which he has effectively applied to his extensive career in pharmaceutical quality management. His expertise in areas like sterility assurance, CAPA (Corrective and Preventive Actions), change management, and GxP computerized systems showcases a strong alignment between his academic background and professional accomplishments.
Experience at DuPont Pharmaceuticals
John Maiero's career at DuPont Pharmaceuticals spanned from 1998 to 2003, where he initially worked as a Packaging Technician / Line Leader and later as a Manufacturing Specialist. He gained valuable experience in pharmaceutical manufacturing, which laid the groundwork for his future roles in quality assurance and compliance. His responsibilities likely included supervising packaging lines, ensuring product quality, and collaborating with teams to improve manufacturing processes.
Skills and Industry Contributions
With over 20 years of experience in pharmaceutical manufacturing and quality management, John Maiero possesses a broad skill set that includes risk management, sterility assurance, investigations, and continuous improvement. He notably led a Failure Mode and Effects Analysis (FMEA) risk assessment related to aseptic processing and sterility assurance in 2015. Additionally, he has managed relationships with FDA Compliance and Drug Shortage Staff, demonstrating his capability in handling regulatory interactions and compliance challenges.