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Director, Quality Assurance & Compliance

hace 18 días

Madison

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 approval. 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. • 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 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. • 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 Usona'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 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. We use AI systems to support regulatory research, document review, deviation analysis, inspection preparation, and knowledge management. The Director will be expected to integrate these capabilities into their daily practice and to help evolve how we use them as the tools improve. • 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, • 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 15-25% 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 15-25% 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 clearly-both verbally and in writing-during 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. Environmental Exposure: Ability to traverse manufacturing facilities, clinical trial sites, and laboratory environments while maintaining GxP compliance and safety protocols. Ability to position oneself in various work environments while observing quality and compliance operations. Compensation and Benefits Usona offers competitive compensation commensurate with experience and the scope of this role. Benefits include comprehensive health insurance (medical, dental, vision), a 401(k) retirement plan with employer match, and professional development support. We also value work-life integration and offer flexible approaches to schedules where feasible. Specific compensation details will be discussed with qualified candidates based on experience and qualifications. At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

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