Director, Quality Assurance & Compliance

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.

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.

• 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.

• 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, deviation, and batch record review processes run per SOP and are audit ready
• Own the Approved Vendor List, including annual review, new vendor qualification routing, and quality agreement execution

NDA 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.

• Support the build out of post market safety reporting infrastructure in collaboration with medical and regulatory personnel
• Contribute to REMS material development, ETASU elements, and prescriber/pharmacy certification programs in coordination with Regulatory Affairs
• Establish a product complaint and quality event system appropriate for a commercial stage controlled substance
• Support FDA inspections post approval, including routine GMP and post market inspections

Usona’s pipeline includes additional investigational programs that will…