Director, Quality Assurance & Compliance

Job Description About Client Client 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. Client 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 Client 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. Client'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 Client 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 approval BIMO Inspection Readiness FDA typically conducts a Bioresearch Monitoring (BIMO) inspection following NDA submission. Client 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. 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 Client, 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 NDA approval is expected to include a REMS requirement. The Director will support Client'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 Pipeline Program Development Client's pipeline includes additional investigational programs that will require quality system support from the IND stage. The Director will lead this build. 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 Client 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 Client'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, 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 Quality Management System Own and operate the Client 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 Ensure 21 CFR Part 11 compliance Clinical Trial Quality Serve as the QA representative for active clinical programs Own sponsor oversight obligations and TMF maintenance Provide QA review and sign off on clinical regulatory documents Attend protocol deviation review meetings Vendor and Contract Oversight Qualify and oversee critical vendors Execute and maintain quality agreements Lead or coordinate vendor audits AI Integrated Quality Practice Client operates at the frontier of AI assisted drug development and quality management. Use AI assisted tools for regulatory research, gap analysis, SOP review, and inspection preparation Leverage regulatory intelligence capabilities Apply AI assisted document review and audit analysis Contribute to AI assisted quality workflows Ensure all AI QA processes are documented and inspection ready Client 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 or related field Minimum 10 years of QA experience NDA/BLA submission experience Direct

FDA BIMO

inspection experience Deep GxP knowledge Experience leading a QMS eQMS experience Audit program experience Strong communication skills Ability to collaborate in small teams Preferred Controlled substance program experience REMS or post market safety experience CNS drug development familiarity Small biotech experience AI quality tool exposure CQA 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 Distributed QA coverage A scalable Client QA function Mature processes, distributed ownership Consolidated quality authority AI assisted regulatory intelligence AI native quality practice Working at Client The Director will join a small, dedicated team working at the intersection of science, medicine, and regulatory strategy. This is an onsite position based in Madison, Wisconsin.

Travel required:

15-25%. What We Value We are committed to an inclusive and respectful workplace. Demonstrate inclusion and respect Embrace Emotional & Social Intelligence Comply with legal and regulatory standards Leverage digital tools and AI Physical Demands Office work with extended computer use 15-25% travel Document review and analysis Communication and presentation responsibilities Exposure to labs, clinical sites, manufacturing environments Compensation and Benefits Client offers competitive compensation, health benefits, 401(k), and professional development support. Details will be discussed with qualified candidates.