John Montalto

WORK HISTORY

EDUCATION

ABOUT JOHN MONTALTO

As an accomplished professional specializing in GxP Quality Systems and compliance, I excel in strategically implementing quality systems to drive organizational success. With a strong reputation for expertise in compliance, Quality Risk Management, and Pharmaceutical Quality Systems across the Asia Pacific (APAC) region, I am recognized for my skill as a dynamic public speaker and facilitator. A highlight of my career includes leading a significant project across APAC, overseeing the successful implementation of SAP S/4 HANA across CSL\'s manufacturing and affiliate sites. Looking ahead, my ambition lies in transitioning to a role that integrates business development and growth opportunities while leveraging disruptive technologies. Experiences and successes include- Leading Quality Assurance and Compliance for a site wide SAP implementation - Directing Quality Assurance Systems within USFDA compliant environs - Leading and influencing people to ensure compliant, value adding outcomes - Facilitation and curriculum development in the Life Sciences industries - Quality Risk Management facilitation and system implementation - Consulting and Training to Regulatory Agencies across the world - Consulting and Training to United Nations - Auditing to GMP, ISO and US FDA compliance standards - Establishing third party contract manufacture selection and monitoring programs