BACKGROUND
SKILLS & SPECIAL QUALIFICATIONS
Mr. Rhoades has a distinguished thirty-nine year career in Quality Management, advising pharmaceutical and medical device executives on compliance and strategy. He specializes in post-Warning-Letter remediation and proactive quality system design to ensure successful FDA inspections. Notably involved in the 2008 heparin crisis, he serves on the Board of the Food and Drug Law Institute and has led over 750 projects, generating more than $40 million annually through his expert team’s work in significant Consent Decree cases.
– Mr. Rhoades combines public speaking and project management skills for successful outcomes.
– He has designed quality systems programs leading to FDA approvals for foreign facilities in China, Germany, Indonesia, and Ireland.
– Provides strategic quality advisory services to firms across Europe and India.
– Frequently invited speaker at pharmaceutical and medical device conferences in the US and Europe.
– Authored multiple articles on quality topics, including two books: Risky Business: Managing The Quality of America’s Medicines (2004, 2nd edition) and Sustaining Compliance: Strategies for Maintaining Drug Quality (2005).
Robert (Bob) Rhoades focuses on helping companies navigate the regulatory landscape while keeping pace with their corporate direction and strategy. He is based in Atlanta.
A skilled practitioner of both Quality System Regulation and pharmaceutical cGMPs for nearly four decades, Bob has designed and implemented compliance improvement initiatives for major manufacturers around the world. Known for his talent in guiding clients through crisis events, his history of post-enforcement action guidance speaks for itself as a strong record of re-establishing credibility with the FDA.
Bob previously led the Quality and Compliance consulting practice for Quintiles and served in consulting leadership roles at Becker & Associates and Impact Management Services. He’s also served in key executive positions at Solvay Pharmaceuticals, Bausch & Lomb, and Baxter Healthcare. He holds a Bachelor of Science Degree in Microbiology from Purdue University and a Masters of Business Administration in Operations and Strategy from Lake Forest Graduate School of Management. He serves on the board of the Food and Drug Law Institute and authored the book “Risky Business: Managing the Quality of America’s Medicines,” now in its second edition.
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EDUCATION:
B. S. Microbiology, Purdue University 1978MBA 1988, Lake Forest Graduate School of Management. Focus in Strategic Planning and Operations.
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2017 – Present: Validant, San Francisco, CA (Atlanta, GA Based)
SVP, Client Services
Works with pharma, biotech and medical device clients across the globe to develop and implement effective programs to address quality system and GMP compliance issues that affect company success. Serves clients by assembling and deploying expert service teams to address specific problems typically resulting from deficiency citations by world regulators, including FDA, EMEA, MHRA and others.2009-2016: Quintiles Transnational, Durham, NC (Atlanta, GA Based)
Senior Vice President, Quality & Compliance Services
Works with foreign and domestic clients in the pharmaceutical, medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with regulations by:
•Providing strategic consultation regarding quality systems and GMP/QSR compliance
•Conducting GMP/QSR assessments.
•Performing Mock FDA Inspections and FDA Preparedness Training.
•Developing and implementing quality systems.
•Developing and implementing corrective action plans.
•Assisting in response to Regulatory Authority enforcement actions.
•Investigating suspected fraud and scientific misconduct.
•Assisting clients with US and European Union commercialization plans.
•Presenting GMP/QSR training.2008-2009: Becker & Associates Consulting, Inc., Washington, DC
Established quality systems and consulting practice for this revered regulatory consultancy.
Selected by lead counsel in 2008 to advise in the world-wide heparin contamination crisis.2006-2007: Impact Management Services, Inc., Cary, NC
Integrated quality systems consulting with unique software platform at major multi-national pharmaceutical manufacturer.2000-2006: The Weinberg Group Inc., Washington, DC
Led compliance and quality systems consulting practice and grew this business unit from its inception at Weinberg to $3.5 million in annual billings.
Client activities involved successful 483 and Warning Letter remediations for both pharmaceutical and medical device firms in the US and Europe, as well as establishing compliant quality systems for emerging companies.1994-2000: Solvay Pharmaceuticals, Inc., Marietta, GA | Internal Consultant
Served as Internal consultant to the President/CEO and Executive Committee.
Managed key quality/regulatory action plans, including defense of major product from adverse FDA intervention.
Developed and implemented program to align business strategy and performance management process (Balanced Scorecard)1992-1994: The EdVenture Group, Inc., Rochester, NY | Owner/Principal
Designed and delivered productivity improvement program to more than 2000 Xerox employees in U.S. and Brazil, resulting in more than $10 million in process improvements.
Advised CIBAVision to first ISO 9001 certification.
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