Director, Quality Assurance & Compliance

Director, Quality Assurance & Compliance

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.

BIMO Inspection Readiness

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.

Quality System Operations

Serve as the senior quality leader for Usona, the designated quality authority accountable for active regulatory programs.

Long Term Scope (Years 25)

Post Approval Quality Operations

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.

Pipeline Program Development

Usona's pipeline includes additional investigational programs that will require quality system support from the IND stage. The Director will lead this build.

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.

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.

Quality Management System

Own and operate the Usona QMS, including document control, CAPA, deviations, complaints, audits, vendor qualification, and management review.

Clinical Trial Quality

Serve as the QA representative for active clinical programs through regulatory submission and post approval follow up.

Vendor and Contract Oversight

Qualify and oversee critical vendors including CMOs and CROs.

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.

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

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

Experience leading or overseeing a Quality Management System, including management review processes, governance, and executive reporting (e.g., experience in roles similar to a Management Representative or QMS lead in regulated GxP or ISO environments)

Hands on experience administering an eQMS (ETQ, MasterControl, Veeva, or equivalent)

Experience developing and executing a GxP audit program, including CRO and CMO oversight

Strong written communication skills; experience writing or reviewing regulatory submissions, SOPs, CAPA records, and audit reports

Demonstrated ability to build collaborative relationships in small team environments; experience joining established teams and earning trust before driving change

Preferred

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

Experience in a small sponsor or emerging biotech environment where QA is a multi functional role

Exposure to AI assisted quality tools, regulatory intelligence platforms, or computerized system validation in a GxP context

CQA (Certified Quality Auditor) or equivalent professional certification

What Makes This Role Distinctive

What You're Walking Into - What You're Building Toward

NDA submission for lead program - Post approval commercial quality infrastructure

First time sponsor BIMO inspection - Pipeline program quality frameworks from IND stage

Distributed QA coverage - A dedicated, scalable Usona QA function

Mature processes, distributed ownership - Consolidated quality authority in a single accountable leader

AI assisted regulatory intelligence in production - AI native quality practice as an organizational standard

Working at Usona

The Director, Quality Assurance & Compliance will join a small, dedicated team working at the intersection of hard science, compassionate medicine, and first principles regulatory strategy. The role requires range: deep technical expertise, sound regulatory judgment, and the ability to work effectively in an environment where every person carries substantial responsibility. This is a team that works closely together and values open, direct communication. We are looking for a leader who brings both expertise and humility, someone who listens before they lead.

This is an onsite position based in Madison, Wisconsin. Travel will be required for inspections, vendor audits, and clinical site oversight activities, estimated at 1525% annually, with elevated travel during inspection preparation and submission periods.

What We Value

At Usona, we are committed to creating an inclusive, respectful workplace where everyone can do their best work. We expect all team members to:

Demonstrate inclusion through their own words and actions and be accountable for a safe, respectful workspace.

Act with kindness, curiosity, and respect for others.

Embrace and be open to incorporating Emotional & Social Intelligence (ESI) principles in daily work.

Understand and comply with ethical, legal, and regulatory requirements applicable to the business.

Demonstrate proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

Physical Demands

Office and Remote Work Environment: Ability to remain stationary for several hours at a time while reviewing documents, participating in video conferences, and using computer applications.

Travel Requirements: Ability and willingness to travel 1525% annually, including travel to FDA facilities, manufacturing and contract laboratories, clinical trial sites, and vendor locations. Travel frequency may be elevated during NDA submission preparation and FDA inspection periods.

Computer and Document Work: Ability to use Microsoft Office applications and electronic quality management systems (eQMS platforms such as MasterControl, Veeva, or equivalent). Ability to read, review, and analyze regulatory documents, SOPs, and compliance records for extended periods.

Communication and Presentation: Ability to communicate clearlyboth verbally and in writingduring regulatory meetings, inspections, vendor audits, and internal quality reviews. Ability to present complex regulatory information to diverse audiences, including FDA inspectors, internal teams, and external partners.