Interim Quality Director Services for Pharma, Biotech and Medical Device Sites
A contract head of quality in the seat this month, while the permanent search runs.
Your director of quality resigns on a Friday and FDA could walk in next month. Who leads the quality unit on Monday?
An interim quality director is a contract head of quality who leads your quality unit between a departure and a permanent hire, before an FDA inspection, during 483 remediation or ahead of a site start-up.
Last updated: November 15, 2026
Short answer? An interim. KORE1’s interim quality director services put a contract head of quality in the chair to run your quality unit, which is the group at a drug site with the authority to approve or reject everything the site makes, until a permanent director starts. Nobody plans for this. KORE1 contractors start a median 3 days after the offer (n=1,997, all roles, as of November 2026), and an interim can convert at no fee after 1,040 hours.
Three dates matter. The day your director leaves, the day a permanent one can start, and whatever lands in between.
That middle stretch might hold an inspection, or a set of commitments to FDA after a Form 483, which is the list of observations an inspector hands you at the end of a visit, or a new site that needs its quality system built. The interim covers it. You keep control of the search.
- This page
- Interim heads of quality for drug, biologic and device sites, between a departure and a permanent hire.
- Routed elsewhere
- The crew around the interim during a 483 goes to FDA 483 remediation staffing, and the permanent director goes to pharmaceutical executive search.
This seat sits inside our interim management services, next to the life sciences staffing desk I work from.
When Does a Site Need an Interim Quality Director?
Four situations cover most calls. CAPA, short for corrective and preventive action, is the fix for a problem plus the step that keeps it from coming back, and a tech transfer moves a product’s process to a new site or a new maker. The map shows what the interim owns in each case, what you keep and how it ends.
Trigger-to-cover map
Four situations, read across from the trigger to the handoff.
| Trigger | What the interim owns | What your site keeps | How the engagement ends |
|---|---|---|---|
| A director resigns before an inspection | The readiness plan, preparation for the front room and the open commitments. | The inspection response and the sign-offs your procedures reserve. | Handoff to the permanent director, or conversion after 1,040 hours. |
| 483 remediation is under way | The commitment tracker, CAPA triage and a weekly status to site leadership. | The response letter and the commitments made to FDA. | Handoff when the observations close. |
| A site start-up or tech transfer | The quality system build-out and the hiring plan for the quality team. | Site leadership decisions and the budget. | Handoff to the permanent director. |
| The search runs longer than planned | Day-to-day quality leadership. | The hiring decision. | Handoff on the permanent director’s start date. |
How to read the map
- Solid rule The interim’s leg. This is the work the interim carries.
- Dashed rule Stays with your team. Your own procedures decide who signs.
- Hatched cell The exchange zone, where the interim hands the seat on.
Tell Me When Your Head of Quality Leaves
Give me the departure date, the next inspection or commitment date, the scope of authority and when you need someone. I’ll come back with who I would call first. No pitch deck.
Prefer the contact page? Let’s Connect there instead. Want an hourly quote first? Ask for one.
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What Does an Interim Head of Quality Own, and What Does Your Site Keep?
An interim owns the quality unit’s daily work and nothing your procedures keep for someone else, and that line comes from your own procedures and delegations, so write them down on day one. The interim works inside them.
For a drug site, 21 CFR 211.22 says the quality unit’s responsibilities and procedures must be in writing and followed. Why that unit can’t sit empty is a longer argument. It lives on our pharmaceutical executive search page, so I won’t restate it.
Devices follow a different rule. Since February 2, 2026, the QMSR, FDA’s quality management system regulation in 21 CFR Part 820, has incorporated ISO 13485:2016 by reference. So put in writing who the interim answers to and which quality system responsibilities top management hands over. I’m skipping clause numbers. Check them against your own licensed copy of the standard.
Interim or Fractional, Which Fits the Quality Seat?
- Interim
- Full-time leadership for a defined gap. The seat is empty, and the interim fills it until the permanent hire starts.
- Fractional
- Part-time leadership, ongoing. The seat is filled, and you want senior judgment a day or two a week.
Pick by the chair. Not the word. If an inspection is coming and the chair is empty, you want the first. Contract, interim or fractional compares all three models, so I won’t repeat it here.
Why Not Rush the Permanent Hire?
Because a strong quality leader has options. Several, usually. I think about it the way I think about every scientific search.
“Candidates on the market are like a professional athlete. If they are amazing then multiple companies should be interested in hiring them.”
Dave Manchester, KORE1 Scientific Recruiting
An interim buys you the time to run a search that lands the right leader instead of the first one available. A permanent hire still brings something an interim can’t. Devin Hornick puts it plainly.
“The benefit of hiring full time is quite the opposite. It’s really not super flexible, but you have stability… legacy knowledge.”
Devin Hornick, KORE1 partner
When you’re ready, the permanent search runs through pharmaceutical executive search, where direct hire for the permanent director is 20% of base salary with a 60-day replacement guarantee on the direct hire. Not sure when the seat should open? Read when a small pharma company needs a director of quality.
3 days
median from accepted offer to start, all roles (n=1,997)
1,040 hours
of contract work before an interim can convert to your payroll at no fee
20%
of base salary is the fee on a direct hire of the permanent director
60 days
replacement guarantee on a direct hire, never on an interim or any contract seat
KORE1 placement data 2019 to 2026, export of October 16, 2026. Offer to start is measured from the accepted offer, not from the start of the search, and it describes history, not a promise. Terms as of November 2026. The contract rate method is public.
How Fast Can an Interim Start, and How Is It Billed?
Once you accept an offer, KORE1 contractors start a median of 3 days later, and that figure covers 1,997 placements across every role, measured from the offer and not from the start of the search. It’s history. It isn’t a promise.
- Starts
- Median 3 days after the offer
- Billed
- Hourly, quoted per engagement
- Replacement
- None on contract, 60 days on direct hire
The interim works on a KORE1 contract and bills hourly. Our contract rate index has no quality leadership role, so I won’t publish a number I can’t back up. The rate is quoted per engagement, and an hourly quote starts with the scope of authority you want the interim to hold, the type of site and the date you need someone in the seat.
If a 483 is driving this, the interim needs people underneath. 483 remediation staffing covers the crew.
Can We Keep the Interim If It Works?
Maybe. An interim placed through KORE1 can convert to a direct hire at no fee after 1,040 hours, which is 40 hours a week for 26 weeks.
“If this person completes 1,040 hours, then they are eligible to convert over to full time with that particular company at no additional charge from KORE1.”
Devin Hornick, KORE1 partner
I can’t promise any interim will accept. Some would rather take the next assignment than a permanent chair, and the choice is theirs as much as yours, so raise the question about staying in the first conversation you have with them. Ask early. Put the conversion terms in writing before the first day.
What the Interim Leaves on Your Shelf
Four documents come out of the work, and each one is yours when the interim leaves.
Commitment tracker
Every promise made to FDA, with an owner and a date, on one page your site leaders can read between meetings.
CAPA and deviation triage
Open deviations, meaning times a process drifted from its procedure, ranked by risk so the worst ones close first.
Inspection readiness plan
Who answers in the front room where inspectors sit, and who runs documents in from the back room.
Handoff file
What the permanent director needs on day one, from open commitments to who signs what.
What Site Heads Ask Before Bringing in an Interim Quality Leader
Can an interim sign for the quality unit?
Only if your own procedures and delegations say so. Write the interim into them before day one, and check the regulatory wording that applies to your site against the documents your quality unit already follows, because your written procedures decide who may sign. I can’t give legal advice.
What happens if the interim is not the right fit?
There is no replacement guarantee on a contract seat. The 60-day replacement guarantee covers direct hire only. If the fit is wrong, tell us early. We’ll talk through your options.
How is interim different from fractional?
An interim is a full-time leader for a defined gap. Fractional is part-time and ongoing. Our guide to contract, interim or fractional compares them side by side.
Can the interim help hire the permanent director?
Yes, when you put it in the scope. The interim can write the role, screen finalists and brief your CEO on what the seat needs, while your site keeps the hiring decision.
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