Susan Giddens

About Susan Giddens

Nineteen (19) successful years as a learning and development/organizational change management professional, with ten (10) years as a leader and manager across learning and development, process development, process improvement, GxP requirements, quality and compliance, quality management systems, clinical systems, and inspection readiness. Areas of expertise include:• Envisioning, developing, and executing a short- and long-term strategic approach to build a clinical quality management, process and training function that adds value to the organization.• Leading a diverse and high functioning team; motivating and inspiring a team to execute a new direction under my new leadership.• Quickly establishing and consistently maintaining outstanding relationships with business partners, subject matter experts, clients, and team members• Implementing sustainability processes to ensure GxP requirements are maintained, drive continuous improvement, and always maintain inspection readiness.• Measure department and program effectiveness and report findings to leadership• Conducting comprehensive performance and needs assessment to identify knowledge gaps and recommend new learning opportunities using performance consulting methodology.

Experience

1. Business Owner

   Opi Consulting, Llc

   Apr 2020 — Present

   Contract/Consultant supporting biotechnology and learning and development firms with SOP development, process development, quality and compliance to FDA, ICH and GCP regulations, training strategy, development and implementation and organizational change management activities. Companies include: Ultragenyx, Sana Biotechnology, The Performance Company, CK+Co. for others, please request.

Education

• San Francisco State University

  M.A., Education, Instructional Technologies

  2004 — 2006

• San Francisco State University

  B.A., Political Science

  2002 — 2004

Skills

• Program Management
• E-Learning
• Management
• Project Management
• Biotechnology
• Strategy Implementation
• Learning Management
• Stakeholder Engagement
• Instructor-Led Training
• Training
• Instructional Design
• Clinical Trials
• Pharmaceutical Industry
• Cross-Functional Team Leadership
• Captivate
• Strategy Creation
• Addie
• Crm
• Employee Training