Jeff Naraja

Experience

• 

  XOMA

  Jan 2000 - Jan 2002

  Quality Assurance - Incoming Quality Assurance
• 

  Genentech

  Jan 2002 - Aug 2021

  In my role as Senior Learning Partner, I developed and implemented globally recognized quality documents, aligning training governance and practices uniformly across Roche Pharma Technical Operations. Additionally, I led the Learning Management System 'LMS' implementation activities for the Quality organization, ensuring smooth deployment through effective change management strategies. My Key Accomplishments:• Architected and implemented impactful learning solutions for Pharma Technical Global Quality programs, extending reach and impact across network.• Utilized Lean and Scrum methodologies to optimize daily training operations and processes, enhancing efficiency and effectiveness.• Authored three pivotal global documents to standardize training governance and practices across 13 Roche sites, establishing new learning site in Canada.• Led harmonization of team consisting of seven senior site learning leads in North America and Asia, fostering alignment on global quality systems standards and network training initiatives.• Streamlined global quality training deployment process, resulting in significant improvement in training effectiveness and efficiency. Show less In my previous role, I managed the SSF Production Learn team and oversaw 14 learning experts during significant organizational updates. I implemented lean practices into our daily departmental activities, leading to increased efficiency and productivity.My Key Accomplishments:• Achieved significant reduction in course length and benefited over 1200 on-site learners by enhancing site-wide training programs, including Controlled and Classified Gowning, Global Training Deployments, and Trainer Development Program.• Pioneered robust portfolio management process to monitor Learn projects, integrating daily huddles and lean production methodologies into team processes.• Elevated multiple site training programs, focusing on augmenting knowledge and skills, and successfully streamlined onboarding processes for new GMP employees entering workforce. Show less In my role as Senior Supervisor Manufacturing, I managed the professional development of technicians and aseptic mechanics involved in drug substance final purification and sterile fill operations.My Key Accomplishments:• Ensured continuous inspection readiness and effectively represented operations during health authority and regulatory inspections, demonstrating commitment to compliance.• Achieved and sustained exceptional performance, consistently delivering production targets at or above 95% adherence to schedule targets, on time, and without need for investigations.• Showcased leadership excellence by consistently meeting or exceeding production targets, accomplished through development of high-performing teams focused on efficiency and goal attainment. Show less

  • Senior Learn Partner - Global Quality

    Nov 2017 - Aug 2021

  • Senior Training Manager - Interim Head of Learning

    Apr 2016 - Nov 2017

  • Senior Production Supervisor

    Apr 2005 - Apr 2016

  • Manufacturing Technical Trainer

    Jan 2002 - Apr 2005
• 

  Exelixis

  Aug 2021 - Mar 2024

  In my role as Associate Director of Process, Standards, and Training, I oversaw the successful implementation of clinical quality documentation, an electronic trial master file system, and training protocols. I collaborated with the Digital Transformation team to introduce dashboards for tracking training performance, enhancing efficiency. Additionally, I enhanced our clinical trial study training program by eliminating inefficiencies and optimizing resource utilization.My Key Accomplishments:• Spearheaded design, development, and streamlining of 60+ departmental procedures, process maps, and training quizzes, resulting in heightened GxP/GCP compliance.• Achieved 36% reduction in training curricula for 175-person clinical organization, aligning content with job descriptions and CV inspection readiness standards.• Engineered and automated training curricula assignments for 15+ clinical trial studies, positively impacting 300+ study management team members.• Executed comprehensive training for Veeva electronic Trial Master File system, contributing to enhanced operational efficiency and compliance standards. Show less

  • Associate Director Process, Standards, and Training - Exelixis

    Oct 2022 - Mar 2024

  • Senior Process, Standards, and Training Manager

    Aug 2021 - Oct 2022