Director, Quality Assurance

Director, Quality Assurance & ComplianceUsona Institute is a 501(c)(3) medical research organization dedicated to advancing investigational compounds for the treatment of mental health conditions. Our programs span late-stage clinical development through regulatory submission, and we are preparing for our first NDA filing with anticipated FDA review under Breakthrough Therapy designation. Usona operates as a mission-driven, resource-efficient organization. This role sits at the center of a growing quality function and requires someone who can build quality infrastructure with clarity, integrity, and purpose.
The OpportunityThis is a defining role at a defining moment. The Director, Quality Assurance & Compliance will join Usona at the transition from late stage clinical trial sponsor to commercial drug developer. You will own the quality system, lead inspection readiness, and establish the foundation for continued program growth. The successful candidate will be a hands on leader who can build and scale. In the near term, the work centers on FDA inspection readiness and maintaining QMS and GxP compliance across sponsor, CRO, and clinical site operations. Usona's team is small, close knit, and deeply committed. The quality function here does not operate in isolation; it is embedded in a team where trust, open communication, and mutual respect are foundational. The right candidate will take time to understand existing systems and relationships before proposing changes, and will lead through influence and collaboration rather than authority alone.
Immediate Priorities (First 12 Months)NDA Quality SupportUsona is preparing for its first NDA submission. The Director will own the quality components of this regulatory filing and ensure all supporting documentation meets FDA expectations.
BIMO Inspection ReadinessFDA typically conducts a Bioresearch Monitoring (BIMO) inspection following NDA submission. Usona is a first time sponsor under BIMO scrutiny. The Director will be the operational lead for inspection readiness and serve as QA co host during the inspection.
Quality System OperationsServe as the senior quality leader for Usona, the designated quality authority accountable for active regulatory programs.
Long Term Scope (Years 2–5)Post Approval Quality OperationsNDA approval is expected to include a REMS requirement. The Director will support Usona's post approval quality obligations in coordination with medical and regulatory leadership.
Pipeline Program DevelopmentUsona's pipeline includes additional investigational programs that will require quality system support from the IND stage. The Director will lead this build.
Organizational DevelopmentBuild out the Usona QA function as the organization grows; assess staffing needs and make the case for resources as the portfolio expands.
Core ResponsibilitiesRegulatory Compliance and GxPEnsure organizational compliance with 21 CFR Parts 50, 56, 312, 210/211 (drug substance/product), ICH E6(R3), and applicable FDA guidances.
Quality Management SystemOwn and operate the Usona QMS, including document control, CAPA, deviations, complaints, audits, vendor qualification, and management review.
Clinical Trial QualityServe as the QA representative for active clinical programs through regulatory submission and post approval follow up.
Vendor and Contract OversightQualify and oversee critical vendors including CMOs and CROs.
AI Integrated Quality PracticeUsona operates at the frontier of AI assisted drug development and quality management. This role requires someone who is not just comfortable with these tools but who actively uses them to work at a level of quality and efficiency beyond what traditional methods allow.
QualificationsRequiredBachelor's degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferredMinimum 10 years of progressive experience in pharmaceutical quality assurance, with at least 5 years in a leadership roleDemonstrated experience supporting NDA, BLA, or equivalent regulatory submissions in a QA capacityDirect experience with FDA BIMO inspections as a sponsor representative, QA reviewer, or inspection hostDeep working knowledge of GxP regulations including GCP (ICH E6(R3)), GMP (21 CFR Parts 210/211), and GLP, as well as 21 CFR Parts 50, 56, and 312Experience leading or overseeing a Quality Management System, including management review processes, governance, and executive reporting (e.g., experience in roles similar to a Management Representative or QMS lead in regulated GxP or ISO environments)Hands on experience administering an eQMS (ETQ, MasterControl, Veeva, or equivalent)Experience developing and executing a GxP audit program, including CRO and CMO oversightStrong written communication skills; experience writing or reviewing regulatory submissions, SOPs, CAPA records, and audit reportsDemonstrated ability to build collaborative relationships in small team environments; experience joining established teams and earning trust be