Director, Quality Assurance & Compliance

Promega•Madison, WI

11h•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

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.

Responsibilities

Own the quality components of the NDA 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.