(Senior) Director, Quality

Braveheart Bio•San Francisco, CA

12d

About The Position

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. 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. The Director/Senior Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical and nonclinical quality oversight, data privacy and GDPR, as well as inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). Reporting to the Vice President, Quality, this individual will establish and execute the clinical and nonclinical oversight framework to support global Phase 3 execution, guide clinical development teams, and prepare the organization for future regulatory submissions and commercialization activities. This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, CMC, and external CRO and vendor partners to ensure best-in-class quality oversight across all programs. The Director/Senior 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.

Requirements

Bachelor’s degree in life sciences or related discipline; advanced degree preferred
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
Demonstrated expertise in GDPR and clinical data-privacy compliance, including implementation and management of privacy-related processes in collaboration with Legal
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
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

Nice To Haves

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 (e.g., RQAP-GCP) or quality certification (e.g., ASQ, ISO Lead Auditor)

Responsibilities

Lead clinical and nonclinical quality strategy aligned with global regulatory requirements, risk-based quality principles, and business priorities
Establish fit-for-purpose quality practices that support late-stage development and inspection readiness
Serve as a trusted quality partner to clinical and nonclinical teams, proactively identifying, assessing, and mitigating risk
Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
Serve as the company’s GCP and GLP subject matter expert
Provide quality guidance across nonclinical and clinical development activities
Lead quality oversight of CROs, vendors, and clinical sites through a risk-based oversight model
Direct GCP inspection readiness activities and serve as a key quality leader during health authority inspections
Support computerized system validation for clinical and nonclinical systems, including oversight of validation activities and review of validation documentation
Develop and maintain clinical and nonclinical audit strategies and vendor oversight plans
Direct or perform internal and external audits as needed, including vendor audits, investigator site audits, system audits, and pre-inspection assessments
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, and teams
Collaborate with Legal on the implementation and management of GDPR and data privacy requirements
Support GDPR and data privacy compliance across clinical and nonclinical workflows
Partner with Data Management, IT, and vendors to ensure appropriate handling, storage, and transfer of personal data
Support data protection impact assessments, vendor privacy assessments, and data processing agreements
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
Provide ad hoc quality support across broader GxP activities as business needs evolve
Support GMP drug substance and drug product activities as needed
Support enterprise quality system activities as needed
Contribute to cross-functional quality initiatives, inspections, and issue resolution