Michael O'Neill Email & Phone Number
Vice President of Quality @ Leiters Health
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Michael O'Neill Location
- Denver, CO, US
Michael O'Neill Work
- Vice President of Quality @ (May 2026 - Present)
- Sr Director of Quality @ (November 2024 - May 2026)
- Senior Manager Quality Assurance Systems Monitoring @ (December 2023 - November 2024)
- Sr Manager Quality Assurance Systems Monitoring @ (July 2022 - December 2023)
- Global Quality and Compliance Audit Manager @ (July 2021 - July 2022)
- Quality Manager (Operations Support) @ (April 2019 - July 2021)
- Quality Manager (CAPA and Audit) @ (April 2018 - July 2019)
- Quality Engineer III @ (October 2013 - April 2018)
- QA Team Leader @ (August 2004 - October 2013)
- Quality Compliance Officer @ (March 2003 - August 2004)
- QA officer @ (November 2001 - March 2003)
- QC Scientist @ (July 1998 - October 2001)
Michael O'Neill Education
- Queen's University Belfast
Bachelor of Science - BS (Microbiology, General)
- Ulster University
Post Graduate Certificate (Computing and Information Systems)
Michael O'Neill Skills
- 21 CFR
- 21 CFR Part 11
- Auditing
- Biotechnology
- CAPA
- CAPAs
- Change Control
- Clinical Manufacturing
- Combination Products
- Communication
- Complaint Management
- Compliance Management
- Compliance Training
- Computer Literacy
- Continuous Improvement
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Customer Satisfaction
- Design Control
- Directing Others
- Easily Adaptable
- Environmental Auditing
- FDA
- FDA GMP
- FMEA
- GMP
- ISO 13485
- ISO 14971
- International Regulations
- International Travel
- Key Performance Indicators
- Life Sciences
- Management
- Manufacturing Operations Management
- Medical Device Quality Assurance
- Medical Device Regulation (MDR)
- Medical Devices
- Meeting Facilitation
- Microsoft Excel
- Microsoft Office
- Oral Communication
- Parenteral
- Performance Reviews
- Pharmaceutical Industry
- Pharmaceutical Manufacturing
- Professional Skills
- Project Management
- Quality Assurance
- Quality Auditing
- Quality Management
- Quality Operations
- Quality Risk Management
- Quality System
- Recalls
- Regulatory Examinations
- SOP
- Software Quality Assurance
- Strategic Initiatives
- Subject Matter Experts
- Supplier Management
- Task Assignment
- Time Management
- V&V
- Validation
Michael O'Neill Summary
- Michael O'Neill, based in Denver, CO, US, is currently a Vice President of Quality at Leiters Health. Michael O'Neill brings experience from previous roles at Leiters Health, Pfizer, Seagen and Terumo Blood and Cell Technologies. Michael O'Neill holds a Bachelor of Science - BS in Microbiology, General @ Queen's University Belfast. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Auditing, Biotechnology, CAPA and more. Michael O'Neill has 1 emails and 1 mobile phone numbers on RocketReach.
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