Lenita Y. Sims Spears

Senior Quality Consultant/Senior Regulatory and Compliance Counsel

Lenita is an accomplished attorney and RA/QA Compliance professional with extensive domestic and international experience.  She has expertise in a spectrum of healthcare regulation and compliance disciplines, including merger/acquisition, international business development, contract management, client account management, regulatory program implementation, subcontractor/vendor contracts design and management, commercial acquisitions and incorporations.

 

EXPERIENCE…
  • Accomplished transactional attorney with significant federal contracting experience. Legal investigations and case management of complex pharmaceutical and medical device litigation.  Expert witness and a nationally recognized expert on Federal Drug Administration (FDA) policies and procedures.
  • Managed business integration and regulatory affairs.  Planned and executed worldwide pharmaceutical and medical supplier audits per Food Drug and Cosmetic Act (21CFR820); International Organization for Standardization (ISO13485, ISO17025, and ISO9001), In Vitro Diagnostic Directive (IVDD), and the Medical Device Directive (MDD).  Provision of IT project management, Quality Assurance (QSR/cGMP), Training and Support for ISO 9001:2000, ISO 13485 compliance, and 21 CFR Part 11 Compliance.  Manage domestic (510(k), IDE) and European regulatory submissions for CE Mark and ISO13485 certifications for clients including Ameda, Inc., Siemens, Lohman & Rauscher, OralDNA, Quest Diagnostics, Enterix, Abbott Medical Optics and Hospira, Inc.
  • Adjunct Professor at the John Marshall Law School and University of Phoenix.
  • Developed and implemented strategic quality vision for GE Healthcare Information Technology (IT) division.  Directed interface on behalf of GE Healthcare with external regulatory agencies including the US Food and Drug Administration and ISO 3rd party regulators.  Lead global quality team system re-alignment.  Optimized IT internal audit program.  Managed international team of quality engineers assigned to Milwaukee Wisconsin, Bangalore, India, Shanghi China, and Freiberg Germany.
  • Executed compliance audits for: Food Drug and Cosmetic Act, In Vitro Diagnostic Directive (IVDD), and the Medical Device Directive (MDD) for worldwide sites, including but not limited to Ireland, Germany, Japan, and Puerto Rico.
  • Project Manager, Quality Systems; Customer Complaint Coordinator; GMP Assessor;  Product Assurance Review;  (PAR) Coordinator; Manufacturing Quality Assurance Supervisor; Research Technician.
  • Reduced the number of open system problem issues by 40% and the number of days open by 25%.  Maintained on-time responses to FDA enforcement actions.  Created and successfully delivered new Corporate Quality Management System to 1300 employees in 90 days.  Increased internal customer response time by 5%.
  • Created training plan for a management process that reduced internal auditor noncompliance by 100%.  Established compliance process to reduce cycle-time by 8%.
POSITIONS HELD…
  • Senior Quality Consultant – Bioteknica, Inc.
  • Owner/Senior Regulatory Counsel – Lenita SimsSpears, Attorney at Law
  • Owner/Senior Quality Consultant – LYS Compliance Consulting
  • Adjunct Professor – John Marshall Law School
  • Associate Professor – University of Phoenix
  • Quality Systems Director – GE Healthcare
  • Management Controls Program Manager – GE Healthcare
  • Global QA/RA Manager – GE Healthcare
  • Sr. Internal Compliance Auditor – Abbott Laboratories
  • Quality Systems Project Manager – Abbott Laboratories
  • Good Manufacturing Practices Assessor – Abbott Laboratories
  • Research TechnicianUniversity of Illinois Medical Center Department of Neurosurgery
EDUCATION…
  • J.D., – John Marshall Law School (Illinois Licensed)
  • M.A., Human Development – University of Illinois
  • B.S., Biology – Roosevelt University
  • Certified Auditor/Lead Auditor, BSI
CONTINUING EDUCATION…
  • Risk Management and Root Cause Analysis
  • Lean Manufacturing
  • Infomapping
  • Six-Sigma Quality/SPC