Karen Back-Moore

About Karen Back-Moore

Innovative, degreed Training and Development Professional with 10+ years of experience in designing, developing, and delivering global training programs in regulated industries. Motivated to move from pharmaceutical quality systems to a training leadership role within any industry that highly values a learning culture to drive organizational success. Training & Development | Instructional DesignerEmail: k••••••••@gmail.comAbility to design and deliver comprehensive training programs that address skill gaps, enhance performance, and align business objectives. Apply data-driven insights to evaluate program effectiveness and refine strategies based on quantitative and qualitative feedback.Foster continuous improvement and stay abreast of industry advancements to enhance training quality and relevance. Demonstrate exceptional communication skills and a collaborative mindset to drive impactful learning experiences and support organizational development.CORE COMPETENCIES- Learning and Development (L&D) Strategy- Instructional Design- Project Management- Skill Gap Analysis- Training Delivery- Data Analysis- Stakeholder Management- Continuous Improvement- Communication SkillsACCOMPLISHMENTS- Developed and globally deployed key Quality System and Regulatory Compliance Training programs at Moderna, including Change Control and Good Documentation Practices, enhancing company-wide adherence to regulatory standards and improving onboarding new hires- Led the Incident and Deviation Management (IDM) project Training Workstream at Moderna, creating and delivering a 6-sigma DMAIC methodology workshop that trained over 1,800 colleagues within 18 months, significantly improving deviation management- Co-developed a Deviations Metrics Dashboard and began investigating AI generative text for training assessment, demonstrating innovation in leveraging technology to enhance technology and deviation management systems- Drove the global rollout of Pfizer\'s Human Performance Program and other quality compliance training programs, including Documentation Design for Human Error Reduction, contributing to successful FDA inspections and improving global quality culture- Recipient of multiple awards at Pfizer and Moderna, including Annual Vision Awards for Quality and Colleague Recognition Awards, acknowledging exceptional contributions to training program development, quality systems, and collaborative efforts.Please contact me at 81••••••37 with any learning and development opportunities.

Experience

1. Principal Assoc i Quality Systems-learning & Development

   Replimune

   Jan 2025 — Present · Framingham, MA, US

Education

• Avila University

  Bachelor's Degree, Chemistry, minor Biology

• University of Phoenix

  Master's Degree, Organizational Management

• Northcentral University

  Master's Degree, Education: Global Training and Development

Skills

• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• Continuous Improvement
• Process Improvement
• Leadership Development
• Capa
• R&D
• Gmp
• Pharmaceutics
• Change Management
• Change Control
• Problem Solving
• Standard Operating Procedure (Sop)
• Validation
• Instructional Design
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Training
• Quality System
• Quality Systems
• Analytical Chemistry
• Program Management
• Training Facilitation