Global Regulatory Compliance / QA / Audits
Bob Lucchesi
VP of Global Regulatory Compliance, QA & Audits
Bob Lucchesi helps life sciences companies prepare for audits, strengthen quality systems, qualify suppliers, and respond to regulatory expectations with evidence that holds up. He brings more than 30 years of experience in quality assurance and regulatory compliance across pharmaceuticals, biotech, medical device, engineering, and nuclear industries.
Global audit leadership
Leads quality, regulatory, IT, validation, supplier, and mock FDA audit programs for regulated life sciences organizations.
Regulatory depth
Advises companies on risk-based validation, GAMP, Part 11, data integrity, quality systems, and agency expectations.
Industry reach
Brings 30+ years across pharma, biotech, medical device, engineering, and nuclear compliance environments.
Bob Lucchesi's Credentials
Bob helps regulated teams find the audit issues before regulators, suppliers, or customers find them first.
His work spans global audit planning, execution, and reporting across quality, regulatory, IT, validation, manufacturing, clinical, laboratory, logistics, supplier, and data integrity programs.
Proof points
30+ years of quality assurance and regulatory compliance experience
Lead auditor for global quality, regulatory, IT, validation, supplier, and vendor audits
Audit leadership across pharmaceutical, biotech, medical device, engineering, and nuclear industries
Expertise in risk-based validation, GAMP, enterprise content management, IT security, data centers, and data integrity audits
Primary role
Global regulatory compliance and audits
Helps organizations plan, execute, and defend audit programs across regulated life sciences operations and supplier networks.
Where he helps
Quality systems and inspection readiness
Supports quality assurance, enterprise quality management, QMS controls, data integrity, mock FDA readiness, and remediation planning.
How he helps clients solve it
Bob Lucchesi's Resources
Resources that prove the expertise.
A focused shelf of content tied to Bob's work across global regulatory compliance, quality assurance, audit readiness, and supplier qualification leader.
April 16, 2024
Best Practices for Virtual Audits and Regulatory Inspections
A practical guide for remote supplier qualification, inspection readiness, secure evidence exchange, and defensible audit execution.
April 14, 2022
Is There a Checklist for GCP Audits?
USDM audit guidance on using GCP audit checklists as part of a disciplined quality assurance process.
April 13, 2022
Virtual Audits and Inspections
An on-demand webinar on virtual tours, pre-audit documentation reviews, and remote audit technology.
April 3, 2022
Top 10 Recurring Audit Observations at Life Sciences Companies
Common audit observations USDM sees across life sciences companies, from supplier qualification to validation controls.
March 7, 2021
On-site and Remote Audit Best Practices
Best practices from the USDM Audits team for preparing documentation, people, technology, and workflows before an audit.
Contact Bob Lucchesi
Start a conversation about audit readiness before the agenda shows up and everyone suddenly discovers documentation.
Use the form to route a conversation about quality audits, supplier qualification, mock FDA readiness, GCP audits, data integrity, risk-based validation, or regulatory compliance remediation.