Director, Quality Assurance & Compliance

Reference: 628013Posted: 2026-08-13Location: Fitchburg, WisconsinCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io DescriptionAbout ClientClient 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 OpportunityThis 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 SupportClient 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 productEnsure all open CAPAs, deviations, and protocol deviations are closed, documented, and supported by adequate root cause investigation before submissionWork with Regulatory Affairs to confirm all regulatory submissions referenced in the NDA are on file and current, including IND safety reports and annual reportsConfirm quality agreement currency with all CMOs, contract labs, and CROs contributing to the submission packageMaintain the Trial Master File (TMF) in audit ready condition through the filing dateMaintain awareness of REMS framework requirements under discussion with Regulatory Affairs, as ETASU design will require QA input during NDA review, not after approvalBIMO Inspection ReadinessFDA 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 resourcesConduct or commission vendor audits to surface and remediate findings in advance of FDA inspectionOwn the sponsor oversight narrative: monitoring plan, monitoring visit reports, site qualification documentation, and central monitoring recordsDevelop the document request response protocol and ensure all personnel understand their roles during inspectionComplete SOP review to confirm all clinical and quality documents are current and defensibleMaintain deviation and complaint logs, ensure all outstanding items are resolved, and prepare the QA narrative for the inspection teamQuality System OperationsServe as the senior quality leader for Client, the designated quality authority accountable for active regulatory programsOwn Management Review: preparation, facilitation, and QA sign off on official recordsAdminister or oversee the eQMS for QA owned documentsMaintain and execute the GxP audit program: annual vendor audits, audit reporting, and CAPA follow throughEnsure complaint management, CAPA, deviation, and batch record review processes run per SOP and are audit readyOwn the Approved Vendor List, including annual review, new vendor qualification routing, and quality agreement executionLong Term Scope (Years 2-5)Post Approval Quality OperationsNDA 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 personnelContribute to REMS material development, ETASU elements, and prescriber/pharmacy certification programs in coordination with Regulatory AffairsEstablish a product complaint and quality event system appropriate for a commercial stage controlled substanceSupport FDA inspections post approval, including routine GMP and post market inspectionsPipeline Program DevelopmentClient’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 programsExtend vendor qualification, batch record review, and deviation management processes to new programsApply learnings from the lead program to build efficient quality infrastructure for pipeline programs from day oneOrganizational DevelopmentBuild out the Client QA function as the organization grows; assess staffing needs and make the case for resources as the portfolio expandsDevelop training programs and onboarding protocols for new QA adjacent staffServe as the institutional knowledge holder for quality processes and regulatory inspection historyRepresent Client’s quality posture in interactions with FDA, auditors, investigators, and partnersCore ResponsibilitiesRegulatory Compliance and GxPEnsure organizational compliance with 21 CFR Parts 50, 56, 312, 210/211, ICH E6(R3), and applicable FDA guidancesOwn sponsor level GxP compliance including investigator qualification, informed consent oversight, protocol deviation management, and SAE reportingManage IND annual reports, safety reporting, and regulatory correspondence in coordination with Regulatory AffairsMaintain current awareness of evolving FDA guidance and ICH standardsQuality Management SystemOwn and operate the Client QMS, including document control, CAPA, deviations, complaints, audits, vendor qualification, and management reviewEnsure the eQMS is administered in a state of continuous inspection readinessDevelop and update SOPs, policies, and work instructionsEnsure 21 CFR Part 11 complianceClinical Trial QualityServe as the QA representative for active clinical programsOwn sponsor oversight obligations and TMF maintenanceProvide QA review and sign off on clinical regulatory documentsAttend protocol deviation review meetingsVendor and Contract OversightQualify and oversee critical vendorsExecute and maintain quality agreementsLead or coordinate vendor auditsAI Integrated Quality PracticeClient 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 preparationLeverage regulatory intelligence capabilitiesApply AI assisted document review and audit analysisContribute to AI assisted quality workflowsEnsure all AI QA processes are documented and inspection readyClient does not expect AI to perform quality work. We expect quality professionals who know how to use AI to do better work.QualificationsRequiredBachelor’s degree in life sciences or related fieldMinimum 10 years of QA experienceNDA/BLA submission experienceDirect FDA BIMO inspection experienceDeep GxP knowledgeExperience leading a QMSeQMS experienceAudit program experienceStrong communication skillsAbility to collaborate in small teamsPreferredControlled substance program experienceREMS or post market safety experienceCNS drug development familiaritySmall biotech experienceAI quality tool exposureCQA certificationWhat Makes This Role DistinctiveWhat You’re Walking IntoWhat You’re Building TowardNDA submission for lead programPost approval commercial quality infrastructureFirst time sponsor BIMO inspectionPipeline program quality frameworksDistributed QA coverageA scalable Client QA functionMature processes, distributed ownershipConsolidated quality authorityAI assisted regulatory intelligenceAI native quality practiceWorking at ClientThe 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 ValueWe are committed to an inclusive and respectful workplace.Demonstrate inclusion and respectEmbrace Emotional & Social IntelligenceComply with legal and regulatory standardsLeverage digital tools and AIPhysical DemandsOffice work with extended computer use15-25% travelDocument review and analysisCommunication and presentation responsibilitiesExposure to labs, clinical sites, manufacturing environmentsCompensation and BenefitsClient offers competitive compensation, health benefits, 401(k), and professional development support.Details will be discussed with qualified candidates.