Alisa Ottman
Quality Lead at Key Quality Consulting | Fairfax, Virginia, United States
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Alisa Ottman, as the President and founder of Key Quality Consulting, brings a wealth of expertise and a strategic vision to the life sciences and healthcare sectors. With a robust background that includes pivotal roles at industry giants like Amgen and the United States Pharmacopial Convention (USP), Alisa has honed her skills in developing and implementing Quality Systems that comply with stringent regulatory standards such as CLIA, FDA, and ISO. Her current role as Quality Lead involves not only the creation of compliance benchmarks but also the assessment of complex organizational challenges that require innovative solutions tailored to the unique needs of her clients.
At Key Quality Consulting, Alisa spearheads key projects aimed at enhancing operational efficiencies and ensuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GxP). She excels in program management, where her analytical skills come into play to identify opportunities for business process improvement. Alisa is particularly adept at developing logistics and planning for the launch of new corporate programs, including comprehensive training initiatives and continuous improvement strategies that empower teams and elevate organizational performance.
Her commitment to fostering a culture of quality and compliance is evident in her approach to team building and training, where she emphasizes the importance of aligning quality objectives with strategic business goals. Through her leadership, Key Quality Consulting has become a trusted partner for clients navigating the complexities of regulatory landscapes, ensuring they not only meet compliance requirements but also achieve sustainable growth in an ever-evolving industry.
Quality Lead at Key Quality Consulting in October 2013 to Present
Director Quality System at GeneDx in April 2017 to May 2018
Quality Manager at OHSU in May 2011 to June 2013
Director, Executive Secretariat at U.S. Pharmacopeia in May 2008 to July 2009
Process Improvement Manager at Gene Logic in February 2006 to May 2008
Clinical CRF Reviewer at Human Genome Sciences in February 2005 to January 2006
Quality Assurance Advisor at Amgen in January 2003 to January 2004
Quality Assurance Specialist II at Cerus in April 2001 to August 2003
Quality Assurance Specialist I at Northview Pacific Labs in December 1999 to April 2001
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Communication
Interpersonal Skills
Business Process Mapping
Risk Management
Corrective and Preventive Action (CAPA)
Consulting
Risk Analysis
Program Development
Auditing
Employee Training
ISO 9001
Laboratory Information Management System (LIMS)
Quality Control
GxP
Quality Assurance
FDA
Process Improvement
GMP
Leadership
Data Analysis
Lifesciences
Business Process Improvement
GLP
Strategy
Training
Risk Assessment
Management
Biopharmaceuticals
Cross-functional Team Leadership
Analysis
Quality Auditing
Quality System
Change Management
Biotechnology
Pharmaceutical Industry
Compliance
Team Leadership
Program Management
Quality Management
Team Building
Negotiation
21 CFR Part 11
ISO Standards
Clinical Laboratory Improvement Amendments (CLIA)
Regulatory Requirements
Project Management
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Good Laboratory Practice (GLP)
Life Sciences
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What is Alisa Ottman email address?
Email Alisa Ottman at [email protected]. This email is the most updated Alisa Ottman email found in 2026.
How to contact Alisa Ottman?
To contact Alisa Ottman send an email to [email protected]. (updated on October 30, 2024)
What company does Alisa Ottman work for?
Alisa Ottman works for Key Quality Consulting
What is Alisa Ottman's role at Key Quality Consulting?
Alisa Ottman is Quality Lead
What is Alisa Ottman's Phone Number?
Alisa Ottman's phone (703) ***-*311
What industry does Alisa Ottman work in?
Alisa Ottman works in the Biotechnology Research industry.
Alisa Ottman Email Addresses
Alisa Ottman Phone Numbers
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