Deborah Struller

About Deborah Struller

Pharmaceutical global training professional successfully identifying and bridging…

Experience

1. Senior Training Project Manager, Program Manager, Dev Qa

   Novartis

   Dec 2012 — Present

   Program Manager leading the design, implementation, and maintenance of a global training programs for regulatory and compliance-based training. • Project manager for roll-out of new role-based training model for all pharma associates to ensure qualification of responsible roles and limit training burden. • Ensure effective measurement of training to demonstrate employees are properly trained to perform their roles. • “Training Factory” Lead successfully delivering regulatory and compliance-based training programs including coordination and activities between SOP and Training offices for Process & SOP packages, Quality Systems, Curricula design, etc, according to timeline and budget specifications. • Appointed member of SOP & Training Governance Board (STGB) to represent DevQA Training. • Manage multiple venders and internal stakeholders ensuring budget and timeline adherence, issue resolution or escalation as required. • Business Partner with Chief Medical Office, Patient Safety and Clinical group to drive the development of annual Quality Training Plan. • Review line function specific training to ensure regulatory and compliance training efforts as defined through SOP and QA guidelines.

Skills

• Sop
• Leadership
• Cras
• CRO
• Change Control
• Pharmaceutical Industry
• Gxp
• Regulatory Requirements
• Fda
• Coaching
• Project Management
• Protocol
• Ich-Gcp
• Instructor-Led Training
• Software Documentation
• Instructional Design
• Gmp
• Ctms
• Clinical Development
• Clinical Trials
• Quality Assurance
• Gcp
• Clinical Research
• 21 Cfr Part 11
• Biopharmaceuticals
• Patient Recruitment
• Therapeutic Areas
• Training
• Sop Authoring/Training
• Peer Mentoring
• Biotechnology
• Quality Management
• Drug Development
• Infectious Diseases
• Clinical Systems Implementation