Director, Quality

Braveheart Bio•San Francisco, CA

18d

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 of Quality will serve as a quality leader for Braveheart Bio and will be responsible for manufacturing quality oversight, and inspection readiness for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). Reporting to the Vice President, Quality, this individual will execute the manufacturing quality oversight framework for investigational and commercial product to support global Phase 3 execution and to prepare for future regulatory submissions and commercialization activities. This leader will partner closely with Manufacturing, Regulatory, partners, and CDMOs to ensure best-in-class quality oversight across all programs. As the company grows, this position may include building a small team. This is a hands-on, 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
12+ years of GxP quality experience in the biotechnology/pharmaceutical industry, including deep experience in GMP and GDP oversight and global product development; GCP, GLP, GVP a plus
Strong knowledge of global GMP regulations and regulatory expectations for late-stage clinical programs and commercialization
Proven success executing manufacturing and supply chain quality oversight in a small or emerging biotech environment, including outsourced and virtual manufacturing models
Experience collaborating with vendors and CDMOs, supporting inspection readiness and regulatory interactions
Demonstrated experience with quality oversight of analytical method validation and process validation (PPQ)
Has deep understanding of global regulatory inspection expectations
Skilled in inspection management and communication (clear, concise, controlled responses)
Demonstrated experience providing hands-on functional leadership, with the ability to set clear direction aligned to corporate strategy, regulatory requirements, and program objectives
Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
Demonstrated experience supporting global Phase 1 through commercial products, including interaction with QPs
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 supporting preparation for major regulatory submissions (NDA/BLA/MAA)
Audit certification or other quality certifications (e.g., ASQ)
Experience managing direct reports

Responsibilities

Demonstrates end-to-end oversight of outsourced GMP activities across CDMOs, CMOs, and contract laboratories
Monitors vendors and ensure compliance with Quality Agreements
Uses risk-based approaches to prioritize oversight activities
Manage the quality transition from clinical to commercial manufacturing
Aligns GMP systems with regulatory commitments and post-approval requirements
Maintains focus on sustained state of control
Builds and sustains a continuous inspection readiness culture
Leads teams through mock inspections and document readiness
Ensures rapid, thorough, and strategic responses to inspection findings
Works closely with CMC teams to embed quality expectations into the product development lifecycle
Participates in project team meetings and cross-functional planning activities to ensure quality considerations are integrated into decision-making
Provides ad hoc quality support across broader GxP activities as business needs evolve
Supports quality systems activities as needed
Supports enterprise quality system activities as needed
Contributes to cross-functional quality initiatives, inspections, and issue resolution