Director, Quality Assurance & Compliance

USONA INSTITUTE

Director, Quality Assurance & Compliance

Position Type:
Full Time Exempt|

Reports To:

Chief Executive Officer|

Location:

Madison, WI (Onsite)

About Usona Institute Usona 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 Opportunity

This 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.

Usona 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.

• Own the QA review and sign off on all CTD modules with quality content, including Module 3 (quality) sections for drug substance and drug product
• Ensure all open CAPAs, deviations, and protocol deviations are closed, documented, and supported by adequate root cause investigation before submission
• Work with Regulatory Affairs to confirm all regulatory submissions referenced in the NDA are on file and current, including IND safety reports and annual reports
• Confirm quality agreement currency with all CMOs, contract labs, and CROs contributing to the submission package
• Maintain the Trial Master File (TMF) in audit ready condition through the filing date
• Maintain awareness of REMS framework requirements under discussion with Regulatory Affairs, as ETASU design will require QA input during NDA review, not after approval.

FDA 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.

• Lead and complete mock BIMO inspection activities, working with identified internal and external resources
• Conduct or commission vendor audits to surface and remediate findings in advance of FDA inspection
• Own the sponsor oversight narrative: monitoring plan, monitoring visit reports, site qualification documentation, and central monitoring records
• Develop the document request response protocol and ensure all personnel understand their roles during inspection
• Complete SOP review to confirm all clinical and quality documents are current and defensible
• Maintain deviation and complaint logs, ensure all outstanding items are resolved, and prepare the QA narrative for the inspection team

• Serve as the senior quality leader for Usona, the designated quality authority accountable for active regulatory programs
• Own Management Review: preparation, facilitation, and QA sign off on official records
• Administer or oversee the eQMS for QA owned documents
• Maintain and execute the GxP audit program: annual vendor audits, audit reporting, and CAPA follow through
• Ensure complaint management, CAPA,…