Principal Consultant · Certify Consulting

Jared Clark
JD, MBA, PMP

Jared Clark is the founder and principal consultant of Certify Consulting, a quality and regulatory practice serving FDA-regulated manufacturers and organizations pursuing ISO certification. He holds a JD and an MBA, and he is certified by ASQ, RAPS, and PMI.

"Keep it Simple. Keep it Real."

Jared Clark, founder and principal consultant of Certify Consulting

Background

How a lawyer ended up writing SOPs

Jared Clark started in law rather than in manufacturing. He earned a BS from Utah State University in 2009 and a Juris Doctor from Ave Maria School of Law in 2011, and he spent his early career in compliance work — first as a legal compliance director, then as a senior operations manager, and from 2014 to 2016 as a regulatory compliance attorney at Cannon Law Group in Salt Lake City, where he counseled drug and device manufacturers through FDA inspections and enforcement proceedings.

The same problem kept showing up. His clients understood their products, and they usually understood the specific rule that had caught them, but the quality system underneath — the procedures, the records, the validation work, the training — had never been built to hold weight. By the time a lawyer was involved, the useful decisions had already been made two years earlier by someone who was not thinking about a regulation at all. So in December 2016 he founded Certify Consulting to work at the other end of that timeline, before the inspection instead of after it.

He is a member of the Utah State Bar and does not practice law. The legal training shows up somewhere else: in how he reads a regulation. A rule has a history, an enforcement record, and a set of consequences attached to it, and reading it that way tends to produce different advice than reading it as a checklist to satisfy.

The work since then has covered dietary supplements, OTC drugs, pharmaceuticals, cosmetics, medical devices, and food-contact packaging, and it runs the full length of a certification: gap assessment, quality manual and procedure drafting, process and cleaning validation, computer system validation, internal and supplier audits, training, and sitting with the client through the certification audit itself. He has worked alongside NSF, UL, Intertek, SGS, and ANAB-accredited registrars, and he completed a Lean Six Sigma Black Belt in 2019 and earned his PMP in 2017.

"The most useful thing I can do is tell a client when a project is smaller than they were told it was, or when the standard they are chasing is not the one their customer actually wants. That happens often enough that it is worth saying out loud."

Credentials

Every certification, with a link to verify it

Each certification below links to the issuing body's own verification record, not to a page on this site. Check any of them.

CPGP

Certified Pharmaceutical GMP Professional

American Society for Quality (ASQ)

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CQA

Certified Quality Auditor

American Society for Quality (ASQ)

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CMQ-OE

Certified Manager of Quality / Organizational Excellence

American Society for Quality (ASQ)

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RAC

Regulatory Affairs Certification (Pharmaceuticals)

Regulatory Affairs Professionals Society (RAPS)

RAPS public profile →
PMP

Project Management Professional

Project Management Institute (PMI)

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CSV

Computer System Validation

BioPharma Institute

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CSA

Computer Software Assurance

BioPharma Institute

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PVM

Pharmaceutical Validation Management

BioPharma Institute

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LSSBB

Lean Six Sigma Black Belt

Certified 2019

Certificate available on request

Education

Degrees

  • Master of Business Administration
    Western Governors University · 2015
  • Juris Doctor
    Ave Maria School of Law · 2011
  • Bachelor of Science
    Utah State University · 2009

Affiliations

Professional memberships

  • American Society for Quality (ASQ)
  • Regulatory Affairs Professionals Society (RAPS)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Project Management Institute (PMI)
  • Utah State Bar — member, not in active legal practice
  • American Inns of Court — Barrister
  • Utah Manufacturers Association

Writing and current work

AI systems for regulated industries

Alongside the consulting practice, Jared works on how AI systems should behave inside regulated environments — where an answer that cannot be traced back to a record is not usable, whatever its quality. This is an emerging part of the practice rather than its center, and it grew directly out of validation work: the questions a reviewer asks about a software system turn out to be the same questions worth asking about a model.

He authored two 2025 white papers on the subject: the Artificial Intelligence Exchange (AIX), a protocol for inter-agent interchange, and the Process Protocol Layer (PPL), on transparent and auditable AI for regulated environments. He is also the architect of Nova QMS, a quality management system built around structured, auditable records rather than static documents, and he developed the Certify Consulting LMS, an online GMP training library of more than 150 video modules.

Elsewhere

Independent profiles

Records held by third parties, not by this site.

Talk to Jared directly

Consultations are a free 30 minutes, and you will be talking to the person who would do the work — not to a salesperson who hands you off afterward.

Or email [email protected]