About this opportunity
Promega Corporation lists this Director, Quality Assurance & Compliance opportunity in madison, Wisconsin. Review the employer’s description below for duties, qualifications and application 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
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.
BIMO Inspection Readiness
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
Quality System Operations
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
Long Term Scope (Years 2–5)
Post Approval Quality Operations
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
Pipeline Program Development
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
Apply learnings from the lead program to build efficient quality infrastructure for pipeline programs from day one
Organizational Development
Build out the Usona QA function as the organization grows; assess staffing needs and make the case for resources as the portfolio expands
Develop training programs and onboarding protocols for new QA adjacent staff
Serve as the institutional knowledge holder for quality processes and regulatory inspection history
Represent Usona’s quality posture in interactions with FDA, auditors, investigators, and partners
Core Responsibilities
Regulatory Compliance and GxP
Ensure organizational compliance with 21 CFR Parts 50, 56, 312, 210/211 (drug substance/product), 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
Maintain current awareness of evolving FDA guidance and ICH standards; translate regulatory changes into operational process updates
Quality Management System
Own and operate the Usona QMS, including document control, CAPA, deviations, complaints, audits, vendor qualification, and management review
Ensure the eQMS is administered in a state of continuous inspection readiness
Develop and update SOPs, policies, and work instructions for all quality functions
Ensure 21 CFR Part 11 compliance for all electronic records, audit trails, and electronic signature functions
Clinical Trial Quality
Serve as the QA representative for active clinical programs through regulatory submission and post approval follow up
Own sponsor oversight obligations: monitoring plan, site audit program, central monitoring review, and TMF maintenance
Provide QA review and sign off on protocol amendments, DSURs, study plans, and clinical regulatory documents
Attend protocol deviation review meetings and provide quality oversight of safety events and deviations
Vendor and Contract Oversight
Qualify and oversee critical vendors including CMOs and CROs
Execute and maintain quality agreements with all GxP service providers
Lead or coordinate vendor audits; ensure CAPA follow through on audit findings
AI Integrated Quality Practice
Usona 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.
Use AI assisted tools for regulatory research, gap analysis, SOP review, and inspection preparation, applying critical professional judgment to all AI outputs before reliance on outcomes
Leverage regulatory intelligence capabilities for real time guidance on GxP and FDA standards as they apply to active programs
Apply AI assisted document review and audit trail analysis to improve the efficiency and depth of QA oversight activities
Contribute to the development of AI assisted quality workflows, identifying where automation improves consistency and where human judgment remains essential
Ensure all AI assisted QA processes are documented, validated where required, and defensible under FDA inspection; AI tools augment professional judgment, they do not replace it
Usona does not expect AI to perform quality work. We expect quality professionals who know how to use AI to do better work.
Qualifications
Required
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
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Worksite address
madison, WI, 53774, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.