People profiles
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