From $7,500/month

Fractional Quality Leadership

Fractional
Quality Executive

A senior quality and regulatory leader who works with your team part-time, on a monthly retainer, with regular days on site: setting quality strategy, keeping you ready for FDA, running supplier audits and overseeing validation, without the cost or the search of a full-time hire.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
From $7,500/month
Published price
On site
Regular visits
Monthly
Retainer
Jared Clark, Fractional Quality Executive consultant

What you get

The experience of a head of quality, sized to what you need

Many manufacturers need a senior quality and regulatory leader but not forty hours a week of one, or cannot find one who will relocate. A fractional arrangement fills the role now. These are the parts of it.

Quality and regulatory strategy

The plan for the quality system and the regulatory path for each product line, with priorities your leadership can fund and a regular report on where things stand.

FDA and audit readiness

Standing readiness for FDA inspections and certification audits, support when they happen, and help with any response that follows.

Supplier audits and validation oversight

Supplier audits on the schedule your program needs, and review and approval of validation plans and reports, so the work your team does holds up.

A stronger team

Coaching for your quality staff, help writing the job description and interviewing if you are hiring, and a handover plan if the role later becomes full-time.

How It Runs

Three steps

1

Scope

A call and, usually, a short assessment to agree which responsibilities the role covers, how many hours a month, and how often we are on site.

2

Work

A set number of hours each month, a mix of remote work and scheduled site visits, with a monthly report to leadership on progress, risks and decisions needed.

3

Review

Every quarter we review whether the arrangement is still the right size. When you are ready for a full-time leader, we help hire them.

Scope

When fractional makes sense

The combination many manufacturers are looking for, a quality executive who is also hands-on in validation and knows FDA well, is rare and slow to hire. A common answer is to split the role: hire a capable on-site quality or validation lead, and add a fractional senior leader who sets direction, handles FDA and audits, and coaches the new hire. The company gets both kinds of experience for less than one executive salary.

We have run arrangements like this for years. Our longest-running fractional client has had us as its part-time quality and regulatory leader since 2023, through FDA inspections, certifications and new product lines. The hours, the site schedule and the scope are set to the business, not to a template.

See also supplier audits and FDA inspection readiness, which are often part of the role.

A good fit

  • You are trying to hire a director of quality or regulatory and the search is taking months.
  • You have a good quality team that needs senior direction and FDA experience, not another manager.
  • Your products moved into a more regulated category, such as OTC drugs, and the quality system has to grow up quickly.

Not the right service

  • –You need someone on site five days a week. Then you need a full-time hire, and we can help you find one.

Price And Terms

From $7,500 per month, set to the hours you need

Every engagement is priced in writing after a free 30-minute call and before any work starts. On-site work is scheduled in full days; travel from Salt Lake City is billed at cost, with no markup, after the visit. You own every report and record we produce.

The retainer covers an agreed number of hours each month, including scheduled site days; travel is billed at cost. It runs month to month after an initial term, so it can grow, shrink or end as your team changes.

Frequently asked questions

What does a fractional quality executive cost?

From $7,500 per month. The retainer is set to the hours and site days the role needs, and travel is billed at cost. It runs month to month after an initial term, so it can grow, shrink or end as your team changes.

What is a fractional quality manager?

A senior quality professional who holds a quality leadership role part-time, usually for several companies, on a retainer. The company gets the judgment and experience of a senior leader for a fraction of the cost of a full-time hire.

Can a fractional quality leader be our quality unit's head for FDA?

FDA requires a quality unit with the responsibility and authority to approve or reject. A fractional leader can lead it or advise it, depending on how the role is set up and how much time is on site. We set the responsibilities in writing so there is no doubt during an inspection about who approves what.

How many hours a month does it usually take?

It depends on the size of the site and how much is changing. Arrangements run from a few days a month to about half time, and usually come down as the system stabilizes.

Do you have to be on site?

Some of the work has to be: supplier audits, inspections, floor walks and coaching. Much of it, such as reviewing records, approving documents and planning, can be done remotely. We agree a site schedule up front.

Your Consultant

Who does the work

Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.

Related Services

Often paired with this one

Supplier Audits

On-site audits of your contract manufacturers and ingredient suppliers, with a signed report for your supplier file.

FDA Inspection Readiness and Support

Ready before FDA arrives, and an experienced hand in your back room while the investigator is there.

OTC Drug GMP

Drug GMP under 21 CFR 210/211 for cosmetic and personal care makers moving into OTC products.

Talk about the role you are trying to fill

Book a free 30-minute call. Tell us what the role needs to accomplish in its first year, and we will tell you honestly whether fractional or full-time is the better fit.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting