Director Quality Assurance Compliance

JOB REQUIREMENTS: Job Description 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. Immediate Priorities (First 12 Months) NDA Quality Support 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... For full info follow application link. Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/CBE9A0B64DA443A6 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.