Edward Elmore
Experienced Pharmaceutical Quality Leader I Quality Operations I Regulatory Interactions I Remediation
- Role
- SVP, Chief Quality Officer at CSL
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Edward Elmore
30+ years experience in pharmaceutical manufacturing with responsibilities in Quality Assurance, Quality Control Laboratories, and Manufacturing Science and Technology. Experience includes manufacturing of sterile API and sterile filing of drug product, design/remediation of quality systems, and establishing relationships with multiple regulatory agencies. Experience in small molecule synthesis, large molecule fermentation/purification and live virus vaccine manufacturing as well as sterile filling operations including RABS, isolator, and blow/fill/seal technologies.During my career I have lead lead multiple pharmaceutical quality organizations including an internal network of manufacturing sites, and a broad CDMO network (Brazil, Europe, China, Australia). Global network leadership experience in managing post-merger/acquistion integration of manufacturing sites and quality systems. Responsible for strategy level support in the development of global quality systems as well as managing the assessment and standardization of individual local programs into a network approach, with organizational responsibilties for up to 300 people.Site leadership experience in managing day to day operations and supply issues as well as process improvement, validation, facility expansion, and regulatory inspection management. Throughout my career I have managed numerous regulatory inspection at the site level as well as established and maintained relationships at the corporate level.Specialties: Quality Systems design and governance, organizational leadership/development, regulatory agency interactions and inspection management
Experience
SVP, Chief Quality Officer
Jan 2026 — Present · King of Prussia, PA, US
Chief Quality Officer, Global Quality Assurance and Laboratories
Education
Illinois State University
Bachelor of Science (B.S.), Chemistry
1986 — 1991
Skills
- Quality System
- V&V
- Capa Programs
- Six Sigma
- Gxp
- Pharmaceutical Industry
- Sop
- Fda
- Site Leadership
- Biotechnology
- Laboratory
- Cgmp
- Protein Manufacturing
- Sterile Filling Operations
- Iq/Oq/Pq
- Regulatory Interactions and Inspection Management
- Quality Assurance
- Organizational Leadership
- Quality Control
- Gmp
- Laboratory Operations
- 21 Cfr Part 11
- Validation
- Process Capability
- Fermentation
- Purification
- Cleaning Validation
- Manufacturing
- Testing
- Process Validation
- Capa
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