Kristi R. Sims
Lexington
Summary
Quality assurance executive with extensive experience in FDA 503A compounding and GMP manufacturing. Proven track record in leading successful regulatory audits and enhancing quality management systems. Skilled in team development and ensuring compliance in a highly regulated environment, driving operational efficiency.
Overview
29
29
years of professional experience
Work History
Vice President of Quality
Tailor Made Compounding
Nicholasville
07.2023 - Current
- Engaged in strategic planning and execution for the site as a member of the executive team.
- Directed the development and maintenance of quality management systems for FDA 503A compounding facility.
- Oversees FDA 503A compounding activities, including product development, sterile and non-sterile compounding, and product release, to ensure safety and quality standards.
- Leads annual regulatory and accreditation audits to verify adherence to industry regulations and enhance facility accreditation status.
- Managed customer complaint system to ensure timely resolution of issues.
- Leads strategic initiatives to enhance operational efficiency.
- Increased the compliance team from three to twelve members in three years to support quality systems and culture.
Director of Quality and Regulatory
Summit Biosciences Inc.
Lexington
03.2012 - 07.2023
- Led all on-site audits, including three FDA audits (no 483s) and one EMA audit, securing EU GMP certification.
- Ensured regulatory compliance and managed communications with FDA.
- Directed development and maintenance of GMP quality management and laboratory systems for ANDA and NDA nasal spray products.
- Expanded quality assurance, quality control, and regulatory teams from five to 45 employees over ten years. Mentored staff, fostering professional development and enhancing team capabilities to support company growth.
- Oversaw customer complaint system, ensuring timely resolution of issues and enhancement of customer satisfaction.
- Facilitated project management, ensuring alignment with client expectations and maintaining effective communication throughout project lifecycle.
- Collaborated with cross-functional teams to address quality issues effectively.
Manager of Quality Control Unit/Chemist
Murty Pharmaceuticals, Inc.
Lexington
04.1998 - 03.2012
- Led the development and maintenance of GMP quality management systems and laboratory systems in support of ANDA solid oral drug products.
- Led on-site audits, which included numerous client audits, NIDA, and four FDA inspections (no 483s).
- Conducted testing of solid oral drug products for product development and clinical/commercial supply release and stability programs.
- Coordinated project management, budget creation, and client communications to ensure alignment with project goals.
Associate Chemist
Southern BioSystems
Birmingham
02.1997 - 03.1998
- Conducted quality control for characterization of biodegradable polymers to ensure product integrity.
- Operated laboratory equipment for precise measurements and sample preparation.
- Collaborated with team members on research projects and data collection.
Education
M.S. - Forensic Science
University of Alabama at Birmingham
Birmingham, Alabama01-1997
B.S. - Chemistry
Georgetown College
Georgetown, KY01-1995
Skills
- Quality compliance
- Regulatory strategy
- Auditing procedures
- Project management
- Leadership planning
- Decision making
- Detail orientation
Timeline
Vice President of Quality
Tailor Made Compounding
07.2023 - Current
Director of Quality and Regulatory
Summit Biosciences Inc.
03.2012 - 07.2023
Manager of Quality Control Unit/Chemist
Murty Pharmaceuticals, Inc.
04.1998 - 03.2012
Associate Chemist
Southern BioSystems
02.1997 - 03.1998
M.S. - Forensic Science
University of Alabama at Birmingham
B.S. - Chemistry
Georgetown College