<div class="content-intro"><p><strong>About us:</strong></p> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody">Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.</span></p> </div> <div> <p class="x_MsoNormal">With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.</p> </div> <p> </p></div><p><span style="font-size: 12pt;"><strong>The role:</strong></span></p> <p><span style="font-size: 12pt;">The Associate Director, Quality owns clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams from end to end, and serves as a senior quality advisor across Braveheart Bio's clinical programs. Reporting to the Director, Quality, this individual will make quality decisions within scope, serve as the primary quality contact for assigned vendors and CROs, and direct the work of contractors or junior staff.</span></p> <p><span style="font-size: 12pt;"><strong>Key responsibilities:</strong></span></p> <h1 style="line-height: 1;"><span style="font-size: 12pt;">Quality Strategy & Leadership</span></h1> <ul> <li style="line-height: 1.3; font-size: 12pt;"><span style="font-size: 12pt;">Applies clinical quality strategy for assigned studies and workstreams, aligned with global regulatory requirements and risk-based quality principles</span></li> <li style="line-height: 1.3; font-size: 12pt;"><span style="font-size: 12pt;">Serves as a trusted quality partner to clinical teams, proactively identifying, assessing, and mitigating risk</span></li> <li style="line-height: 1.3; font-size: 12pt;"><span style="font-size: 12pt;">Serves as GCP subject matter expert for assigned programs</span></li> </ul> <h1 style="line-height: 1;"><span style="font-size: 12pt;">Study-Level Quality Oversight</span></h1> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Develops and executes clinical quality oversight plan</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Serves as the clinical QA representative on study teams, providing quality input from protocol development through study close-out</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Reviews protocols, monitoring plans, data management plans, and other key study documents for GCP compliance</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Oversees quality risk management for studies in line with ICH E6(R3)</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Reviews and trends protocol deviations, assesses significant quality events and potential serious breaches, and drives investigations and CAPA to effective closure</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Leads GCP inspection readiness activities for assigned scope; serves as a quality lead during health authority inspections</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Oversees TMF quality and inspection readiness</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Provides quality oversight of study-specific clinical systems, including EDC, eTMF, IRT, and eCOA, to ensure compliance with 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) expectations</span></li> </ul> <h1 style="line-height: 1;"><span style="font-size: 12pt;">Audit, Oversight, & Compliance</span></h1> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Develops and maintains audit strategies and vendor oversight plans for assigned scope</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Leads deviation investigations, root cause analysis, and CAPA management for assigned scope</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Directs contracted auditors performing investigator site audits, including the risk-based audit plan, report review, finding classification, and CAPA follow-up</span></li> </ul> <h1 style="line-height: 1;"><span style="font-size: 12pt;">Cross-Functional Collaboration</span></h1> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Works closely with clinical development teams to embed quality expectations into study planning, startup, execution, and closeout</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Participates in project team meetings and cross-functional planning activities</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Works with Quality Compliance and Risk Management to support inspection r