Summary
Overview
Work History
Education
Skills
Timeline
Generic

Lisa Shurtz

Gilbert

Summary

Regulatory affairs professional with strong expertise in ensuring compliance and navigating complex regulatory landscapes. Known for effective team collaboration and delivering results, adaptable to changing needs. Skilled in regulatory submissions, risk management, and policy development. Valued for strategic thinking, clear communication, and reliability.

Overview

30
30
years of professional experience

Work History

Regulatory Affairs Manager

McKesson
11.2022 - Current
  • Manage customer due diligence processes, preparing detailed reports and documentation to support regulatory decisions and audit readiness.
  • Review and analyze customer data to identify and validate business models and controlled substance ordering and dispensing trends.
  • Utilize software tools and open-source to support regulatory decisions.
  • Engage with pharmacy compliance personnel and internal stakeholders to support CSMP processes and ensure regulatory alignment.
  • Collaborate with sales account managers and regulatory leadership to support strategic compliance initiatives.
  • Monitor and interpret Federal and State regulations to ensure adherence to controlled substance compliance requirements.
  • Improve operational excellence through enhancements in people, processes, and technology.
  • Apply sound judgment and logic-based decision-making to resolve complex regulatory issues in a fast-paced environment.
  • Support team collaboration and contribute to a culture of integrity, accountability, and continuous improvement.
  • Key Contributions: Recognized for contribution and commitment to Chains Regulatory Team through due diligence completion, quality of reports, ownership of process improvement, collaboration with team members, internal stakeholders, and customers, and demonstration of I2Care and ILEAD values. Accomplishments include competition of 242 due diligence reports between 7/1/2023 – 6/30/2025 (32.6% Annual Reviews/Proactives and 58.2% TCRs), EOS committee member since 3/6/2024, and resource for new employees.

Customer Compliance & Diversion Surveillance Supervisor

Covetrus
06.2022 - 11.2022
  • Oversaw Regulatory Affairs Team managing reporting and strategy to ensure compliance with federal and state regulations and internal regulatory integrity.
  • Effectively led and managed 15 Customer Compliance & Diversion Surveillance professionals in a diversity of roles to support regulatory initiatives and assigned workloads.
  • Directed customer due diligence program using analytical tools to include audits, IQVIA, Tableau, and open-source to monitor controlled substance distribution in the pursuit of identifying trends and detecting potential diversion risks.
  • Conducted data analysis to segment customers based on business models, base codes purchased, and purchase volumes. Defined maximum ordering thresholds per base code aligned with each customer segment. Applied IQVIA rules to initiate Suspicious Order Monitoring (SOM) reviews for customers exceeding established thresholds.
  • Conducted investigations into all theft/losses and follow-up SOM requests, reporting the findings to DEA and state regulatory agencies.
  • Developed and delivered training programs to internal and external stakeholders on diversion detection and prevention.
  • Prepared Distribution Centers for audits and inspections by regulatory and accreditation bodies.
  • Key Contributions: Recognized for ingenuity and expertise in regulatory affairs program implementation and management. Ensured operational excellence and improved customer experience, establishing regulatory affairs procedures and policy to include launch of IQVIA, customer segment identification and thresholds, improved communications across departments, and implementation of best pharmaceutical supply practices.

Consultant
03.2022 - 07.2022
  • Prepared detailed due diligence reviews for retail pharmacy clients, identifying complex issues related to diversion, fraud, waste, and abuse.
  • Reviewed and analyzed customer data to support onboarding, threshold change requests, and validation of controlled substance ordering and dispensing trends.
  • Executed data mining, auditing, and fraud analysis to support regulatory compliance and identify suspicious activity.
  • Interviewed pharmacy and healthcare personnel to conduct interviews and gather intelligence for compliance assessments.
  • Collaborated with internal compliance teams and external customers to resolve regulatory issues and promote best practices.
  • Communicated investigation findings and compliance actions to leadership and cross-functional teams.
  • Key Contributions: Recognized for exceptional reports, analysis, investigations, and organizational skills within regulatory affairs and controlled substance compliance.

Diversion Control Analyst

Independent Pharmacy Cooperative
03.2021 - 04.2022
  • Prepared comprehensive customer assessments, investigations, and remediation actions through interviews, analysis of customer data, data mining, IQVIA, and strategic, logic-based decisions.
  • Researched and completed audit requests from DEA, PBMs, Boards of Pharmacy, CMS, HHS, and other regulatory agencies.
  • Educated internal teams and customers to resolve product compliance issues and mitigate fraud, deception, or unsafe practices.
  • Investigated accounts and complex issues related to potential fraud, waste, and abuse involving customers and stakeholders.
  • Developed SOPs and instructions related to customer assessments, data usage analysis, and reporting.
  • Maintained regulatory records and systems to ensure audit readiness and compliance documentation integrity.
  • Key Contributions: Recognized for contribution and commitment to the Regulatory Team through report competition, process improvement initiatives, creation of training materials, collaboration with team members, internal stakeholders, and customers.

Claims Generalist Associate

Progressive
11.2018 - 03.2021
  • Managed a high volume of claim files from initiation to resolution.
  • Prepared detailed investigation reports through interviews, scene reconstruction, evidence examination, in accordance with state traffic law.
  • Communicated claim resolution to all parties involved, resolving conflict when presented.
  • Key Contributions: Recognized for analytical skills, thorough investigations, efficient claim closures, and outstanding customer service. Awarded Employee of the Month and Triple Crown achievement for exceeding position requirements.

Police Analyst / Lead Background Investigator

Scottsdale Police Department
12.2014 - 08.2019
  • Effectively led, managed, and trained personnel and volunteers.
  • Hired employees through complex hiring processes involving job requirements, salary negotiation, benefits, and relocation.
  • Partnered with managers to define job conditions and expectations.
  • Ensured legal compliance and adherence to policies and regulations while meeting business goals.
  • Crafted new policies and procedures using best practices, work groups, and PERF guidelines while mitigating risk.
  • Authored a comprehensive 78-page background investigations manual and 44-page background questionnaire.
  • Reduced investigator timelines by streamlining background investigation processes.
  • Identified and resolved complex problems impacting operations management.
  • Developed training materials, administered programs, and presented highlights to various audiences.
  • Planned and executed projects from conceptualization to completion.
  • Key Contributions: Recognized for contribution and dedication to Hiring Unit through process improvement in key areas, exceptional background investigations, and project completion.

Police Officer/Detective

Mesa Police Department
01.1996 - 10.2014
  • Effectively led, managed, and trained Fusion Center personnel, military personnel, and volunteers.
  • Supervised police personnel in high-sensitivity investigations and regulatory compliance initiatives.
  • Hired employees through complex hiring processes involving job requirements, salary negotiation, benefits, and relocation.
  • Reviewed and advised on policy risks, and developed new procedures using best practices and industry standards.
  • Investigated employee misconduct and performance issues, and composed detailed investigative reports.
  • Led criminal investigations and covert operations targeting organized crime, controlled substances, fraud, and other regulatory concerns.
  • Developed expertise in data mining, intelligence gathering, and analysis to support regulatory and compliance objectives.
  • Planned and executed strategic projects from concept to completion, contributing to operational excellence.
  • Key Contributions: Recognized for contribution to excellence in each position held throughout career. Earned 4 individual commendations, 3 unit citations, and 2 teamwork awards for dedication, exceptional leadership, efficiency, and initiative.

Education

Master of Science - Public Administration

Arizona State University
Tempe, AZ
01.2002

Bachelor of Science - Criminal Justice

Northern Arizona University
Flagstaff, AZ
01.1994

Skills

  • 2 years 9 months McKesson Regulatory Affairs Manager
  • 9 years managerial experience
  • 15 years of relevant experience in regulatory compliance with 25 years in law enforcement
  • Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict
  • Responsible for the highest number of due diligence reports for Chain Regulatory Affairs Managers over the past 2 years
  • Displayed proficiency in producing detailed due diligence reports derived from sound judgment and logic-based decision-making to resolve complex regulatory issues in a fast-paced environment
  • Strong leadership capabilities resulting in effective working relationships with team members, internal stakeholders, and customers
  • Proven commitment to process improvement and operational excellence through people, processes, and technology
  • Organized, results-driven, resourceful, and can use tact and sound judgment when dealing with direct reports, customers, and peers

Timeline

Regulatory Affairs Manager

McKesson
11.2022 - Current

Customer Compliance & Diversion Surveillance Supervisor

Covetrus
06.2022 - 11.2022

Consultant
03.2022 - 07.2022

Diversion Control Analyst

Independent Pharmacy Cooperative
03.2021 - 04.2022

Claims Generalist Associate

Progressive
11.2018 - 03.2021

Police Analyst / Lead Background Investigator

Scottsdale Police Department
12.2014 - 08.2019

Police Officer/Detective

Mesa Police Department
01.1996 - 10.2014

Bachelor of Science - Criminal Justice

Northern Arizona University

Master of Science - Public Administration

Arizona State University

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Lisa Shurtz