Jay Baraj

Global Learning Manager @Roche

Mississauga, ON, CA

Led the Learning & Development Workstream of the Global Deviation & CAPA Redesign project- Adapted the Global learning programs to support the Roche network and end users with capability building and successful implementation of the updated requirements. Led development of Deviation Management, Change Control, and CAPA Global Training program improvements, fulfilling commitments to FDA, Swissmedic, and COFEPRIS- Assessed associated global quality documents and executed strategy for training deployments in alignment with regulatory commitments and associated procedure/IT-related updates. Facilitator for Investigator Certification Program (ICP)- 4 week Program focused on building capabilities of investigators to conduct timely and effective investigations for critical deviations. Co-led development of Global Root Cause Analysis (RCA) Capability Building program in partnership with Deviation Task Force. Assessed and managed training retirement activities in alignment with decommissioning of the Global Deviation Management System. Project Managed Oceanside University from concept to Phase 1 implementation- Program streamlined employee onboarding roadmap, while providing clearly defined career development opportunities into Manufacturing, Quality Compliance, and Facilities & Engineering. Member of Global Quality Risk Management Team (6 month rotation)- Led development of Quality Management System IT updates to allow for more accurate linking of Change Control actions and Risk Mitigation actions, further contributing to a fully integrated OneQMS platform. Led strategy for developing the newly formed Cell and Gene Therapy organization’s Training Matrix development, liaising with the organizations Training Leads and facilitating the initial learning assignments for learners across the network.

Ryerson University

Bachelor's degree