Last updated: September 25, 2026
By Dave Manchester, Scientific Recruiting, KORE1
When does a small pharma company need a director of quality? Most need one by the time their lead program leaves phase 1 and full CGMP under 21 CFR Part 211 applies, sooner if they add a second CDMO or face a pre-approval inspection.
Here’s a quicker test. Who at your company can say no to a batch?
If the honest answer is “the CEO, probably” or “our CDMO’s QA people,” you’re closer to this hire than you think. Small drug companies run on a handful of people doing three jobs each. That works for a while. Then it doesn’t. The quality job gets too big to be anybody’s third job.
I recruit quality leaders for pharma companies, biotechs, and contract manufacturers through KORE1’s life sciences staffing group. Director-level quality searches are the ones where timing matters most, and calling a year late is an easy mistake to make. I’d rather you call me early and hear “not yet.” Sometimes that’s the right answer.
What a Director of Quality Actually Owns
A director of quality at a pharmaceutical company owns the quality system itself. That means the SOPs, deviation and CAPA programs, change control, supplier and CDMO oversight, training records, and the final call on whether a batch is released. They answer for all of it when FDA or a partner audits.
The regulation behind that last part is short. 21 CFR 211.22 gives every drug maker’s quality control unit the final say on incoming components, work in progress, and finished product. Then comes the line founders skip. The unit also approves or rejects drug product “manufactured, processed, packed, or held under contract by another company.”
Read that twice if you outsource everything. I did.
It means your CDMO’s quality unit signing off on its own work doesn’t finish the job. Yours has to sign too. FDA’s 2016 quality agreements guidance for contract manufacturing puts it about as bluntly as a federal agency ever puts anything: “No matter who tests the products, the owners’ quality units are ultimately responsible for ensuring that the products are manufactured in accordance with CGMP. A quality agreement does not change that.”
So the question was never whether you need a quality unit. You do. From day one. The question is when that unit needs a full-time leader, and how senior.
Phase 1 Buys You Time, Not a Pass
This is the part most founders get half right.
21 CFR 210.2(c) exempts most phase 1 investigational drugs from Part 211. Big relief, on paper. The same paragraph ends the exemption the moment that drug is used in a phase 2 or phase 3 study or goes to market. And even inside phase 1, FDA’s 2008 guidance on CGMP for phase 1 investigational drugs recommends assigning someone “to perform QC functions independent of manufacturing responsibilities, especially for the cumulative review and release” of each batch.
Independent. That word does a lot of work. Your process development lead can’t review and release the batch they just made.
At phase 1, a good QA consultant or a contract QA lead usually covers it. Two days a week. Maybe less. The trouble is that the handoff to phase 2 tends to arrive fast, often right behind a financing round, and a real director of quality search takes months to run from first call to start date. My rule of thumb is to open the search when your phase 2 protocol is being written, not when the first phase 2 batch is being scheduled. By then you’re hiring under pressure. Pressure makes people settle.
Six Moments the Seat Stops Being Optional
Phase 2 is the most common trigger. It isn’t the only one. Here’s how I’d read the calendar.
| What just happened | What changes for quality | Who can usually hold it until then |
|---|---|---|
| Your first phase 1 batch is being made | FDA recommends someone independent of manufacturing review and release each batch | A senior QA consultant or contract QA lead |
| The program moves into phase 2 | Part 211 applies in full. Written procedures, a quality unit with release authority, change control | Nobody part-time, in my opinion. This is the usual hiring point |
| You add a second CDMO or a separate testing lab | Two quality agreements, two audit programs, two sets of deviations landing on your desk | A QA manager, if a director is already coming |
| You bring manufacturing or a QC lab in-house | You now have your own QC unit to staff, qualify, and defend | Very hard to cover without a quality head on site |
| An NDA or BLA is on the calendar | A pre-approval inspection (pre-license, for biologics) will judge your quality system for commercial readiness | Too late to start the search. It should already be done |
| A partner or acquirer schedules diligence | Their auditors read your quality system like an investigator would | Whoever wrote the system has to be in the room |
The “who can hold it” column is my judgment, not a regulatory requirement. A strong senior QA manager can carry a lot. A weak one can’t.
Two rows deserve more words.
The second CDMO sneaks up on people. One contract manufacturer is a relationship. Two is a program. You now have two quality agreements to negotiate and keep current, two audit schedules, two sets of deviation reports with different templates and different clocks, and two quality teams who each think their way is the normal way. Your company needs one person who stays the constant. If that somebody is also your head of CMC, one of those jobs is going to slip, and it’s rarely the one with a launch date attached. It’s quality.
The inspection row is newer than it looks. FDA revised its pre-approval inspection compliance program, 7346.832, with the new version taking effect on August 10, 2026. Objective 1 is still “Readiness for Commercial Manufacturing,” which asks whether the site has a quality system built to control commercial operations, including batch release, change management, and investigations. Objective 4 is titled “Commitment to Quality in Pharmaceutical Development.” Read that title again. That’s an investigator looking at how you ran quality back in development, not just how you run it now. A director hired six weeks before the inspection can’t go back and rewrite two years of development history. Honestly, nobody can.
The Four-Person Company Problem
The first question I ask a founder is what their actual worry is. Most of the time it’s a version of one worry that managers at small science companies share. They don’t have a strong enough technical team to hit their goals. Not a weak team. Just a thin one.
I once worked with a startup that had four employees. My team ended up hiring across every department they built, technical and non-technical, and the company grew enough to close its first funding round and eventually afford its own recruiting team. I’ll be straight with you. That story isn’t about a director of quality. It’s about the people who were there first. Every one of them started out doing everything. Growing up meant handing pieces of “everything” to people whose whole job was that one piece.
Quality is the hardest piece to hand off, and the most dangerous one to keep.
Hard to hand off, because the founder who wrote the first SOPs at a kitchen table knows every shortcut in them, every exception, and every batch that almost went the other way. Dangerous to keep? Look at ICH Q10, the quality system guidance FDA adopted back in 2009. It hands senior management “the ultimate responsibility to ensure an effective pharmaceutical quality system is in place,” and in the same breath mentions that regional rules require “an independent quality unit/structure.” A CEO who also approves batches isn’t independent of anything. Most of them know it. What they haven’t found yet is the person.
Director, Head, or VP of Quality?
Small pharma titles? A mess. A VP of quality at a 15-person biotech might run a department of two. A quality manager at a large CDMO might run a whole site. What matters is scope. Here’s how the titles usually line up.
| Title | What it usually means at a small company | Typical reporting line |
|---|---|---|
| Quality manager | Runs one function, usually QA operations or the QC lab, inside a system someone else owns | Director of quality or head of quality |
| Head of quality | Whatever the company needs it to mean. Often the first quality hire, with the title left open on purpose | CEO, sometimes COO |
| Director of quality | Owns the quality system. SOPs, deviations, CAPA, change control, supplier and CDMO oversight, batch disposition | CEO, never the head of manufacturing |
| VP of quality | Owns quality across several sites or products, sits on the leadership team, often covers regulatory compliance too | CEO |
My advice for most companies making this hire for the first time is director, or head of quality with director-level scope. A VP title at 20 people can box you in. When you’re 150 people with two commercial products, where does that person go next? And plenty of strong candidates would rather be the first director at a company with a real pipeline than a VP in name only. Title inflation also works against you in the search itself. The people who respond to a VP posting at a tiny company are often the ones who most want the title.
Pay follows scope. The federal wage data doesn’t break out director of quality on its own. For a rough anchor, look at Bureau of Labor Statistics figures for industrial production managers, the federal code that holds quality managers and directors. At pharmaceutical manufacturers in May 2025, its 75th percentile came to $169,920 and its 90th to $215,360. A director who runs the QC lab is sometimes coded as a natural sciences manager instead, and in pharma that code’s May 2025 median was $197,590. I broke down the whole range in my quality manager salary guide for pharma and CDMOs, so I won’t redo it here. For a quick check on your own number, the salary benchmark assistant is free. Add equity at a venture-backed company. The good candidates ask about it early. Often before salary.
Where the Seat Sits on the Org Chart
Short section. It matters more than its length suggests.
The director of quality should report to the CEO. Not to the head of manufacturing, not to the head of CMC, and not to the VP of operations. The reason is the release decision. If the person who can stop a batch reports to the person whose bonus depends on shipping it, you’ve built the conflict right into the org chart, and a good investigator will spot it from the chart alone. Candidates spot it too. The good ones tend to ask about the reporting line early, and the wrong answer can end the conversation. I don’t blame them.
What to Look For When You Hire One
Every resume at this level says “built a quality management system.” Great. So did a lot of people who inherited one and renamed the folders. Here’s what I actually screen for, and none of it looks the same on paper.
- Has hosted an FDA inspection as the person in the room, not the person pulling documents in the back room. Ask them to walk you through the worst hour of it.
- Written a quality agreement from a blank page and negotiated it with a CDMO that pushed back.
- Can you picture them telling your CEO no? Ask about the last batch they refused to release, and who was unhappy about it.
- Stood up an eQMS such as Veeva Vault QMS or MasterControl, or moved a company off paper. Knowing the software matters less than knowing why the first configuration was wrong.
- Phase-appropriate judgment. The director who builds a commercial-grade system for a phase 1 program will burn your cash. The one who treats phase 2 like phase 1 will burn your inspection.
- Comfortable being a department of one for a while.
That last one kills a lot of otherwise perfect candidates. Somebody who ran a 40-person quality organization at a large manufacturer may have never written an SOP without a document control team behind them, routed a draft through a review workflow somebody else maintained, or trained a new hire on it personally. Some love the change. Some last three months.
How you run the search matters too. For a director-level quality hire at a small company, I’d usually recommend a retained executive search, because the best candidates are rarely looking and the slate needs to be built on purpose, which is the work our executive recruiters do. For a senior manager or a head of quality at a smaller scope, direct hire recruiting through our pharmaceutical recruiters often does the job for less. If you need someone to hold the seat while the permanent search runs, a contract QA lead through our pharmaceutical staffing agency desk can cover release and deviations in the meantime.
What Founders Ask Before They Open the Req
We’re still preclinical. Is a director of quality premature?
Almost always, yes. Before your first clinical batch, a part-time QA consultant who knows phase-appropriate CGMP is usually enough. Spend the director budget on the science and revisit it when phase 2 planning starts.
Can a consultant legally be our quality unit?
For a while, often. The role has to be written into your procedures, and the person has to be independent of manufacturing. What you can’t outsource is the responsibility. FDA’s quality agreement guidance is clear that the owner’s quality unit stays accountable no matter who does the work, so whoever holds the role needs real authority, not just a signature line.
Director of quality or VP of quality, does the title change who applies?
It does. A VP title at a small company pulls in more candidates chasing a title bump and can scare off people who think the scope is inflated. Director, with a clear path to VP once you’re commercial, usually brings the better slate.
Should our first quality hire be a QA or a QC person?
QA, if you outsource manufacturing and testing. Your first job is overseeing other people’s quality systems, and that’s a QA skill. If you run your own lab, the answer shifts, and my guide to QC vs QA in pharma goes through that split in detail.
How long does a director of quality search take?
Months, not weeks. It runs longer than a manager search. The strongest candidates are employed, many are mid-project, and most will want to meet your CEO and see a site before they move, because leaving a stable quality job for a small company is a real bet on your science and your funding. Add their notice period and possibly a relocation, and you can see why I push founders to start while they’re still at phase 1.
Can our head of regulatory affairs also run quality?
Sometimes. At a very small company, for a while, it can work. The two jobs collide when you’re filing and being inspected in the same season, which is exactly when you need both done well. Split them before the NDA or BLA work starts.
Before You Post the Job
KORE1 started recruiting in 2005. A year after placement, our hires stay put at a 92% rate, and that’s the figure I watch most on searches like this one. On a seat like this, retention is the whole point. A director of quality who leaves after a year takes the history of your quality system with them, and the next one spends six months rebuilding trust with your CDMOs.
If you’re trying to figure out whether it’s time, or you already know it is, let’s connect. I’m happy to tell you it’s too early. Really. You can also find me on LinkedIn.
