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.

Responsibilities

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.

Immediate priorities include NDA quality support, BIMO inspection readiness, and quality system operations. Long-term scope includes post-approval quality operations, pipeline program development, and organizational development.

Immediate Priorities (First 12 Months)

• 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

Long Term Scope (Years 2–5)

• 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
• Partner with Regulatory Affairs and CMC to establish the quality framework for new IND filings and early phase clinical programs
• Extend vendor qualification, batch record review, and deviation management processes to new programs

Core Responsibilities

• Ensure organizational compliance with 21 CFR Parts 50, 56, 312, 210/211, ICH E6(R3), and applicable FDA guidances
• Own sponsor level GxP compliance including investigator qualification, informed consent oversight, protocol deviation management, and SAE reporting
• Manage IND annual reports, safety reporting, and regulatory correspondence in coordination with Regulatory Affairs
• Own and operate the Usona QMS, including document control, CAPA, deviations, complaints, audits, vendor qualification, and management review

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferred
• Minimum 10 years of progressive experience in pharmaceutical quality assurance, with at least 5 years in a leadership role
• Demonstrated experience supporting NDA, BLA, or equivalent regulatory submissions in a QA capacity
• Direct experience with FDA BIMO inspections as a sponsor representative, QA reviewer, or inspection host
• Deep 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 312

Preferred Qualifications

• Experience with Schedule I or II controlled substance research programs (DEA compliance, security protocols, inventory management)
• Experience developing REMS materials or post-market safety reporting infrastructure
• Familiarity with CNS or psychiatric drug development