Retained, partner-led search for the Quality leaders who carry a company's regulatory and manufacturing risk: Chief Quality Officer, VP Quality, Head of QA. Diagnostic-first, calibrated to your stage, not a résumé keyword match.
Source: FDA Complete Response Letter transparency release, 2025.
Hiring that person is a governance decision, not an HR task. A Head of Quality owns the systems that make quality repeatable and defensible to a regulator: the GxP framework, inspection readiness, supplier and CDMO oversight, and data integrity. Get the system right and the audits are quiet. Get it wrong and it surfaces at the worst possible moment, in a pre-approval inspection or a warning letter. This is the Durable mandate from our CTO Mandate Framework: quality systems that survive inspections, shortages, and turnover.
Quality is not one hire. The profile changes as the risk changes. A diagnostic you can run on your own company.
The first quality system and the GMP posture that lets you make clinical-grade material a regulator will accept.
GCP/GMP quality across a growing program, and the oversight muscle to manage quality at a contract site you do not control.
Inspection readiness becomes board-level risk. The inflection where most companies first need a Chief Quality Officer.
Systems maturity: quality that holds across volume, sites, shortages, and turnover, not by heroics.
Every Quality search begins with a diagnostic across the stakeholder base: what the business actually is, where it needs to go, and where the board and management disagree about what the role requires. We build a function-specific maturity framework calibrated to your stage, and assess every candidate against the Durable mandate: can this leader build a quality system that survives an inspection, a supply shock, and the departure of the person who built it. Retained, partner-led, and diagnostic-first.
Typically at the pre-approval inflection, when inspection readiness and commercial quality systems become board-level risk. Before that, a VP or Head of Quality usually carries the function. The trigger is the pivotal campaign and the pre-approval inspection, not headcount.
QC owns testing, confirming material meets specification. QA owns the system: the processes, documentation, and controls that make quality repeatable and defensible to a regulator. Senior Quality leaders are hired primarily for the QA-and-systems judgment.
Against the Durable mandate from our CTO Mandate Framework: whether the leader can build quality systems that survive inspections, shortages, and turnover, not whether their résumé lists the right acronyms. Every candidate is scored on the same structured rubric.
Thirty minutes. A structured read on the role. We tell you whether search is the right product, whether the brief reflects the company you are actually inheriting, and whether the leadership architecture sits where it needs to be for your next capital event.
