Kristi Sanford

About Kristi Sanford

I am currently responsible for developing and maintaining leading edge practices for our operations function, focused on effective solutions and continual improvement. As a leader, I create empowered teams who are engaged champions of their areas of expertise.I consider myself an operations, compliance and quality professional, having hands-on experience with corporate integrity agreements, healthcare law compliance, marketing and promotional compliance, and development of compliance program elements.I have served as an internal expert for state/federal marketing and disclosure law components including transparency reporting (Sunshine/Open Payments), disclosures and compliance certifications. I have also been able to build compliance monitoring and auditing programs based on risk assessments, business profiles and mandated requirements (CIA).In the past, I both led and supported quality systems building expertise in internal processes and systems, databases, clinical study reports, critical documentation, investigator sites, and vendors/subcontractors. I am a skilled facilitator of pharmaceutical, biotechnology and regulatory audits of varying scope and size including FDA, DEA, CLIA, and Independent Review Organizations (IRO).Specialties: Medical Operations, Educational Grants, Investigator Initiated Studies, Clinical Study Management, Healthcare law (e.g, Stark, AKS, FCA), Compliance Program Development and Monitoring, CIA Implementation, GxP auditing, CLIA/CAP experience, CAPA Program Development and Maintenance, Risk Mitigation, Internal Investigations, Regulatory Inspections, Technical Writing, Training

Experience

1. Head, Us Content Operations and Peer Education (Operational Excellence Strategic Planning)

   UCB

   Aug 2018 — Present · Smyrna, GA, US

Education

• The University of Texas at Tyler Graduate School

  Master of Business Administration - MBA, Health/Health Care Administration/Management

  2018 — 2019

• Faulkner University

  JD, General Law

  1997 — 2000

• Seton Hall University School of Law

  Health Care Compliance Certificate, Health Care Law

  2011 — 2011

• Auburn University

  BS, Medical Technology

  1995 — 1996

• Auburn University

  BS, Laboratory Technology

  1991 — 1995

Skills

• Quality Assurance
• Biotechnology
• Cross-Functional Team Leadership
• Lean Thinking
• Validation
• Lean Six Sigma
• CRO
• Life Sciences
• Training
• 21 Cfr Part 11
• Contracts
• Process Improvement
• Compliance
• Monitoring
• Data Analysis
• Six Sigma
• Gxp
• Quality Auditing
• Glp
• Policy
• Auditing
• Transparency
• Risk Management
• Change Control
• Regulatory Affairs
• Regulatory Submissions
• Quality System
• Ich-Gcp
• Pharmaceutical Industry
• Sop
• Fda
• Quality Management
• Aggregate Spend
• Internal Audit
• Gmp
• Clinical Development
• Clinical Research
• Capa
• Management
• Third Party Vendors