30+ Years of Industry Excellence Pharma & Med Device Quality Leadership
Expert consulting from a seasoned chemist and Sr. Director of Quality with over three decades in pharmaceutical and medical device industries. Bridging scientific expertise with regulatory excellence.
Areas of Expertise
Comprehensive solutions for pharmaceutical and medical device companies, backed by hands-on industry leadership.
GMP & Quality Systems
Comprehensive GMP audits and QMS implementation for pharmaceutical and medical device manufacturers. Real-world insights from an active Sr. Director of Quality.
Chemistry & Lab Expertise
Deep scientific foundation as a chemist, providing technical guidance on analytical methods, specifications, and laboratory compliance.
Medical Device Compliance
Regulatory strategy and quality oversight for medical devices, including FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.
Your Trusted Quality Partner
With over 30 years of hands-on experience in the pharmaceutical and medical device industries, I bring a unique combination of scientific expertise and quality leadership to every engagement. As a chemist by training and a current Sr. Director of Quality, I understand the challenges you face from the inside out.
My 20+ years of consulting experience has equipped me to help organizations of all sizes navigate complex regulatory landscapes while maintaining operational excellence.
30+
Years in Industry
20+
Years Consulting
2
Industries
Why Work With Me?
- Active Industry Leader — Currently serving as Sr. Director of Quality, bringing real-time insights.
- Scientific Foundation — Chemist background ensures technically sound, science-driven solutions.
- Dual Industry Expertise — Deep knowledge in both pharma and medical device regulations.
- Proven Track Record — Two decades of successful consulting engagements.
Get in Touch
Ready to elevate your quality and compliance standards? Let's discuss how I can support your organization's goals.