Director – Quality

The role:

The Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late-stage clinical program in hypertrophic cardiomyopathy (HCM).  Reporting to the Vice President, Quality, this individual will execute the clinical oversight framework to support global Phase 3 execution, guide clinical development teams, and prepare the organization for future regulatory submissions and commercialization activities. This is a high-exposure role requiring a senior quality leader who can independently evaluate complex clinical quality issues, identify material risks, and make well-supported recommendations that preserve data integrity, subject protection, regulatory compliance, and inspection readiness. This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection-ready clinical quality oversight across all programs. The Director may also build and lead a small quality team as Braveheart grows.  This is a hands-on, strategic, and foundational role for a lean, fast-moving biotech entering late-stage development.

Key responsibilities:

Quality Strategy & Leadership

• Lead clinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities, while supporting non-clinical quality activities as needed
• Establish fit-for-purpose quality practices that support late-stage development, clinical data integrity, inspection readiness, and regulatory submissions. Serve as a trusted quality partner to clinical and nonclinical teams, proactively identifying, assessing, and mitigating risk.
• Provide clear, well-supported quality recommendations to cross-functional teams and senior leadership, including appropriate escalation of material risks and proposed paths to resolution.
• Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness

GCP/GLP Quality Oversight

• Serve as the company’s GCP and GLP subject matter expert
• Provide quality guidance across nonclinical and clinical development activities
• Develop and execute clinical quality oversight plans, including study-level, CRO, vendor, site, system, and data-focused oversight activities
• Lead quality oversight of clinical trials using a risk-based model
• Provide quality oversight of clinical trial conduct, protocol compliance, informed consent, investigator/site compliance, safety reporting interfaces, TMF quality, essential documents, monitoring quality, and issue escalation
• Assess clinical quality and data integrity risks including adjudication processes, data transfer, and data reconciliation
• Support computerized system validation for clinical and nonclinical systems, including oversight of validation activities and review of validation documentation
• Evaluate clinical computerized systems and data flows for data integrity risk

Oversight & Compliance

• Manage or support targeted clinical oversight activities, including investigator site audits, clinical system/process audits, data focused reviews, and pre-inspection assessments, as needed. Lead deviation investigations, root cause analysis, and CAPA management related to clinical and nonclinical activities.
• Ensure timely and effective resolution of quality issues
• Maintain inspection readiness across clinical and nonclinical activities, documentation, systems, vendors, and teams, in coordination with broader inspection readiness activities

Data Integrity & Clinical Data Quality 

• Review and interpret clinical quality signals, including protocol deviations, monitoring findings, audit findings, data discrepancies, CAPAs, TMF gaps, safety reporting, and vendor performance trends
• Partner with other functions and vendors to identify risk areas and develop mitigation strategies

Cross-Functional Collaboration 

• Work closely with clinical development teams to embed quality expectations into study planning, startup, execution, and closeout
• Participate in project team meetings and cross-functional planning activities to ensure quality considerations are integrated into decision-making
• Serve as an independent quality voice, able to challenge assumptions, identify gaps, and drive resolution while maintaining effective working relationships
• Communicate quality issues clearly and concisely, including the potential impact, recommended actions, and rationale for escalation or resolution

GxP Quality Support (As Needed)

• Provide ad hoc quality support across broader GxP activities as business needs evolve
• Support enterprise quality system activities as needed
• Contribute to cross-functional quality initiatives, inspections, and issue resolution

Required experience & skills:

• Bachelor’s degree in life sciences, health sciences or related discipline; advanced degree preferred
• Demonstrated understanding of hospital and clinical care environments, gained through direct healthcare experience (e.g., nursing, allied health, or medical background) and/or experience supporting clinical trials in academic medical centers, hospitals, CROs, or the biopharmaceutical industry
• At least 10 years of GxP quality experience, including deep experience in GCP oversight and global clinical development
• Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
• Proven success establishing and executing clinical and nonclinical oversight in a small or emerging biotech environment
• Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
• Experience developing clinical quality oversight plans, including study, CRO, site, system, and focused data evaluation
• Demonstrated ability to independently assess complex clinical quality issues and develop well-supported recommendations that are scientifically, operationally, and regulatorily sound.
• Demonstrated ability to evaluate clinical data integrity, endpoint reliability, documentation quality, monitoring effectiveness, vendor data flows, and inspection readiness of clinical trial data.
• Demonstrated ability to evaluate clinical data integrity, endpoint reliability, documentation quality, monitoring effectiveness, vendor data flows, and inspection readiness of clinical trial data.
• Demonstrated experience with computerized system validation for clinical and nonclinical systems in a regulated environment
• Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Strong quality judgment, including the ability to identify material clinical quality risks, escalate appropriately, and drive issues to resolution across functions and external partners.
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills:

• Experience in rare disease, cardiovascular, or specialty disease clinical development
• Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
• Experience with nonclinical quality oversight, GLP compliance, or nonclinical vendor oversight
• Working knowledge of GDPR and clinical trial data privacy requirements
• Audit and/or quality certification (e.g., CQA, RQAP-GCP, ISO Lead Auditor)
• Experience with ICH E6(R3), risk-based quality management, centralized monitoring, quality tolerance limits, and critical-to-quality factors
• Experience evaluating CRO and vendor data integrity, including data transfers and transformations

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Base Salary Range: $195,000 - $230,000