Love
People first. Then the function.
- Every voice in the room, including the newest one
- Teams that want to do good work, not just pass audits
It’s fixable. Let’s find out what ‘it’ is.
Inherited a 483, a homemade QMS, or a quality system nobody owns? 25 years in pharma quality. The first conversation is free.
Start a conversation
How I work
Four letters, already in the name
Ask
What are you actually trying to do?
- Your goals before my fixes
- Root cause work that gets past “human error”
Know
The system, the regulation, the real problem.
- GMP, FDA inspections, CMO oversight, tech transfer
- The fix lands on the cause, not the symptom
Deliver
Finished work, not a dependency.
- Durable: it keeps running after I leave
- Measurable: results you can point to
What I help with
Quality first, applied where it’s needed
The core is pharmaceutical quality management. The rest is what a quality leader runs into anyway.
Quality systems and GMP
Building or repairing a QMS, CAPA and deviations, complaints, supplier qualification, audits, and getting ready for an FDA inspection or answering one.
Connecting systems
ERP, LIMS, eQMS and spreadsheets that don’t talk to each other. Making the data line up so the people stop being the integration layer.
Documents and standards
SOPs people actually follow, templates that hold up, and standards that work across sites.
Responsible AI adoption
Using AI tools in regulated work with human review, verification and data controls built in. My Microsoft 365 setup, this brand, its templates and this site were built in three and a half days that way. Here’s how.
Free SOP
Using LLMs in regulated work
An adaptable SOP template for generative AI in GMP environments, built around human review. Free to use and adapt under CC BY 4.0.
A story
Ask me about the Motown song
The one I wrote about a deviation, and why it got us to a better root cause than a stern meeting would have.
“I have known and worked with Josh Radke for more than 20 years, and his expertise has been invaluable to me throughout that time. When Pharma Source Direct needed interim leadership for our Quality and Regulatory department, Josh stepped in with very little direction. He took charge of a team that needed steady, experienced leadership and earned their trust quickly. When we had a product that was potentially out of specification, he developed a thorough risk assessment that gave us a clear, defensible basis for deciding whether it was feasible to use. Josh has seen nearly every situation compounding wholesale can present. He has worked directly with FDA on numerous occasions and understands both the regulations and how the agency interprets and enforces them, and that perspective is rare. When there is a problem, Josh will solve it. I recommend him without reservation.”
Reaching out is the hard part. The rest is just work.
Tell me what’s going on. The first conversation is free, and you’ll get a straight answer about whether I’m the right fit.