Director – Clinical Quality

Braveheart Bio

. Serve as a senior quality leader responsible for clinical quality oversight and inspection readiness for the late-stage hypertrophic cardiomyopathy clinical program .

Posted 11/6/2026full-timeRemote • California • United StatesSenior💰 $200,000 - $290,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in GCP quality oversight, regulatory compliance, and inspection readiness for late-stage clinical programs. Proven ability to lead quality strategies, manage cross-functional teams, and ensure adherence to global GxP regulations.

Highest-signal resume keywords

GCP Quality OversightGlobal Clinical DevelopmentRegulatory Submissions PreparationComputerized System ValidationGDPR Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP OversightQuality Oversight StrategiesRisk AssessmentClinical Deviation InvestigationsCAPA ManagementInspection ReadinessData Privacy ComplianceQuality Study Oversight PlansRegulatory InteractionsVendor Oversight

Soft Skills

Strong Communication SkillsCollaborative ApproachProblem-Solving AbilityProactive MindsetAdaptability

Tools & Technologies

Clinical SystemsData Management ToolsQuality Compliance SystemsValidation Documentation

Certifications & Qualifications

Audit CertificationQuality Certification (e.g., ASQ)

Industry Keywords

GxP RegulationsLate-Stage DevelopmentRare Disease Clinical DevelopmentCardiovascular Clinical DevelopmentNDA/BLA/MAA Preparation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as a senior quality leader responsible for clinical quality oversight and inspection readiness for the late-stage hypertrophic cardiomyopathy clinical program
Establish and execute the clinical oversight framework supporting global Phase 3 execution
Guide clinical development teams and prepare the organization for regulatory submissions and commercialization activities
Partner with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, and external CRO and vendor partners on quality oversight
Build and potentially lead a small quality team as the company grows
Lead clinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities
Establish fit-for-purpose quality practices for late-stage development and inspection readiness
Serve as the company’s GCP subject matter expert and provide quality guidance across clinical development activities
Lead risk-based GCP quality oversight of CROs, vendors, clinical laboratories, and clinical sites
Direct GCP inspection readiness activities and serve as a key quality leader during health authority inspections
Support computerized system validation for clinical systems, including oversight of validation activities and review of validation documentation
Develop and maintain clinical quality study oversight plans
Develop inspection readiness strategies with Quality Compliance and Risk Management
Lead clinical deviation investigations, root cause analysis, and CAPA management
Ensure timely and effective resolution of quality issues
Maintain inspection readiness across clinical activities, documentation, and teams
Collaborate with Legal on GDPR and data privacy requirements
Partner with Data Management, IT, Legal, and vendors on personal-data handling, storage, and transfer
Support data protection impact assessments, vendor privacy assessments, and data processing agreements
Provide quality support to Clinical Operations, Biometrics, Pharmacovigilance, Medical/Clinical Development, Medical Affairs, Nonclinical, and other functions
Participate in project team meetings and cross-functional planning
Provide ad hoc quality support across broader GxP activities
Contribute to cross-functional quality initiatives, inspections, and issue resolution

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, or related discipline; advanced degree preferred
At least 10 years of GCP quality experience, including deep experience in GCP oversight, global clinical development, and late stage development
Strong knowledge of global GxP regulations (GCP, GLP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
Proven success establishing and executing clinical oversight in a small or emerging biotech environment
Experience developing quality oversight strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
Demonstrated expertise in GDPR and clinical data-privacy compliance
Demonstrated experience with computerized system validation for clinical systems in a regulated environment
Strong written and verbal communication skills with a collaborative, team-oriented approach
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
Experience in rare disease, cardiovascular, or specialty-disease clinical development
Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
Prior experience with data privacy frameworks beyond GDPR (e.g., CCPA)
Audit certification or quality certification (e.g., ASQ)
Experience with GLP (21 CFR Part 58 and OECD) a plus
Employment authorization required; Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires

Benefits

Comp & perks

Annual bonus eligibility
Equity eligibility
Comprehensive benefits offering