Ed Morris

Professional Background

• Develops and implements IT and operational strategies and solutions to accelerate post-merger integration projects including GMP applications, process automation, and IT infrastructure
• Led the successful integration of eight pharmaceutical sites in six countries over a three year period while consistently driving down costs
• Life Sciences domain expertise sector including pharma, biologics and medical devices development, manufacturing and commercial operations
• Well versed in FDA and global regulations related to Quality Management, Clinical Development, Regulatory Affairs, and HIPAA compliance
• Hands-on experience with planning and managing complex multi-stream programs governing the transition of GMP & GCP systems
• Leadership of multiple work streams, project managers and stakeholders
• BS in Management Information Systems, Gartner certified IT Project Management
• Strategic advisor to pharmaceutical executive management to reduce the cost of quality management and drug development

M&A Skills & Expertise

• TSA Negotiation
• FDA Compliance
• Program Management
• Due Diligence & Risk Assessment
• Governance and Reporting
• Regulatory Affairs
• Technical Operations
• Quality Assurance
• Budgeting & Forecasting
• Root Cause Analysis
• Resource Allocation
• Vendor Management
• Product Development

Professional Experience

• Sanofi / PTx Transition Manager, Seattle, WA
• GSK / Avara Transition Manager, Aiken, SC
• Pfizer / Avara Transition Manager, Milan
• AstraZeneca / Avara Transition Manager, Bristol, UK
• Astellas / Avara Transition Manager, Norman, OK
• UCB / Avara Transition Manager, Reims France
• Merck / Avara Transition Manager, Arecibo, PR
• Quality Consultant, Cytokinetics
• Remediation Consultant, Merck, Rahway, NJ
• Validation Team Lead, Novartis, Suffern NY