Julie Larsen

Julie Larsen Current Photo 08-12-15

Principal/Director, Inspection Readiness Services

Julie has more than 20 years experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years leadership experience in Quality operations and compliance). She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decree, Warning Letter and 483 responses.

EXPERIENCE…
  • Principal, BioTeknica, Inc.
  • Facilitated successful FDA compliance inspection under Consent Decree which resulted in substantial compliance determination. Managed coordination of six inspection teams comprised of approximately 45 personnel, including preparation and training of 75 key subject matter experts and management of Third Party consultant personnel.
  • Served as key management representative and liason with Third Party executives to complete quality system remediation activities related to Consent Decree.
  • Developed and successfully lead inspection readiness strategy to prepare four international invitro diagnostic manufacturing sites for FDA inspections and PMA approvals which resulted in NAI / VAI results.
  • Lead team who developed strategy and model for simulated audit preparation and support team roles for FDA inspection readiness Corporation wide.
  • Assisted immunoassay instrument manufacturing site with quality system remediation associated with Warning Letter, responsible for coordination of 3rd party quality system certification of quality system improvements, and preparation for successful follow up FDA inspection to warning letter.
  • Lead or played a key role in writing responses to and constructing the associated corrective action plans for multiple Warning and Untitled letters and 483 which successfully addressed regulatory compliance findings.
  • As Director of Quality for Commercial Operations was responsible for the worldwide complaint handling system, all associated device corrections, and customer communications
  • As Director of Quality for hematology instrument manufacturer lead quality system remediation effort and was responsible for quality strategies, quality planning and the quality system construct and implementation.
  • As Corporate compliance auditor was responsible for conducting FDA compliance audits at pharmaceutical, invitro diagnostic, nutrition, and hospital product manufacturing sites world wide.
  • Lead efforts on multiple occasions for multiple sites to complete ISO 9001, ISO 13485, and CMDCAS requirements and complete successful certification and surveillance audits.
  • As GMP Compliance Officer of pharmaceutical manufacturing facility was responsible for strategy and completion of internal audit program, FDA inspection readiness and management, and completion of DEA requirements.
POSITIONS HELD…
  • Director, Inspection Readiness Services – BioTeknica, Inc.
  • Senior Director Compliance and Auditing – Abbott Diagnostics Division
  • Director Quality Commercial Operations – Abbott Diagnostics Division
  • Director Quality – Abbott Hematology
  • Manager Division Compliance – Abbott Diagnostics Division
  • Compliance Auditor – Abbott Corporate Regulatory and Quality Science
  • GMP Compliance Officer – Abbott Pharmaceutical Products Division
  • Analytical Quality Assurance Lab Supervisor – Abbott Diagnostics Division
  • Medical Technologist, Section Head Tuberculosis – Rush St. Lukes Presbyterian Hospital
EDUCATION…
  • B.S., Medical Technology – Rush University, Chicago, Illinois
  • B.S., Science and Liberal Arts – Monmouth College, Monmouth, Illinois
CONTINUING EDUCATION…
  • 21 CFR Parts 210, 211, 806, 820
  • Certified Quality Manager (CQM)
  • ISO Lead Assessor
  • Six Sigma DMAIC