John Koukoutsis
Sterile Drug Manufacturing, Microbiology, Sterility Assurance, Quality
- Role
- Senior Advisor (Executive Director), Sterility Assurance, Global Drug Parenteral Netwok, Quality at Eli Lilly and Company
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About John Koukoutsis
Eli Lilly and Company leverages advanced sterility assurance and microbiology leadership to ensure compliance with global regulatory standards. As Director of Sterility Assurance, the focus is on harmonizing sterility practices across manufacturing sites, including sterile drug substances and biologicals. Expertise includes supporting operational excellence, quality investigations, and implementing robust microbiological controls that align with Good Manufacturing Practices. With over two decades in pharmaceutical manufacturing, contributions have advanced sterile API, drug substance, and drug product quality on a global scale. Known for fostering a culture of continuous improvement, Curia achieved significant harmonization in sterility assurance during their tenure. A Certified Master Black Belt with Lean Six Sigma expertise, the mission is to drive innovation and uphold the highest quality standards in pharmaceutical production.
Experience
Senior Advisor (Executive Director), Sterility Assurance, Global Drug Parenteral Netwok, Quality
May 2025 — Present
Education
McGill University
Bachelor of Science, Food Science and Analytical Chemistry
1997 — 1999
McGill University
towards a Microbiology and Immunology B.Sc. degree
1994 — 1996
McGill University
Master of Science 2002, Food Microbiology and Safety
1999 — 2002
The Ohio State University
Professional Certificate, Management
2011 — 2011
Villanova University
Master Certificate, Lean Six Sigma - Black Belt
2011 — 2012
Skills
- Quality Assurance
- Profit
- Biotechnology
- Cross-Functional Team Leadership
- Validation
- Quality Investigations
- Recruiting
- Customer Service
- Life Sciences
- 21 Cfr Part 11
- Process Improvement
- Contract Management
- Gamp
- Marketing
- Six Sigma
- Gxp
- Aseptic Processing
- Microbiology
- Glp
- Cleaning Validation
- Windows 2000
- Validation Master Plans
- Validation Reports
- Teamwork
- Computer System Validation
- Lims
- Change Control
- Capas
- Market Research
- Leadership
- Budgets
- Sales
- Quality System
- V&V
- Pharmaceutical Industry
- Sop
- Fda
- Technology Transfer
- Quality Control
- Gmp
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