Associate Director, Quality (Clinical)

Braveheart Bio; San Francisco (CA); Hybrid; USD 175,000 - 210,000; Full time

Job summary

Braveheart Bio, a clinical-stage biopharmaceutical company focused on hypertrophic cardiomyopathy, seeks an Associate Director, Quality to own quality oversight for assigned studies and vendors. You will serve as a senior quality advisor across clinical programs and lead quality decisions within scope, reporting to the Director, Quality.

You will develop quality strategies, ensure GCP compliance, manage audits and CAPA, and guide inspections and TMF quality.

Qualifications

• Bachelor’s degree in life sciences or related discipline.
• Minimum 8 years of pharma/biotech Quality experience.
• Strong knowledge of GCP regulations and regulatory expectations for late-stage clinical programs.
• Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness.

Responsibilities

• Owns clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams from end to end.
• Serves as senior quality advisor across Braveheart Bio's clinical programs.
• Directs work of contractors or junior staff and acts as primary quality contact for vendors/CROs.
• Develops and executes clinical quality oversight plans for studies.
• Leads GCP inspection readiness activities and supports health authority inspections.
• Oversees TMF quality and inspection readiness and ensures 21 CFR Part 11/EU Annex 11 compliance.

Skills

GCP knowledge

Quality leadership

Audit strategy

Vendor oversight

Quality systems

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

EDC

eTMF

IRT

eCOA

Job description

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.

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 role:

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.

Key responsibilities:

Quality Strategy & Leadership

• Applies clinical quality strategy for assigned studies and workstreams, aligned with global regulatory requirements and risk-based quality principles
• Serves as a trusted quality partner to clinical teams, proactively identifying, assessing, and mitigating risk
• Serves as GCP subject matter expert for assigned programs

Study-Level Quality Oversight

• Develops and executes clinical quality oversight plan
• Serves as the clinical QA representative on study teams, providing quality input from protocol development through study close-out
• Reviews protocols, monitoring plans, data management plans, and other key study documents for GCP compliance
• Oversees quality risk management for studies in line with ICH E6(R3)
• Reviews and trends protocol deviations, assesses significant quality events and potential serious breaches, and drives investigations and CAPA to effective closure
• Leads GCP inspection readiness activities for assigned scope; serves as a quality lead during health authority inspections
• Oversees TMF quality and inspection readiness
• 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

Audit, Oversight, & Compliance

• Develops and maintains audit strategies and vendor oversight plans for assigned scope
• Leads deviation investigations, root cause analysis, and CAPA management for assigned scope
• Directs contracted auditors performing investigator site audits, including the risk-based audit plan, report review, finding classification, and CAPA follow-up

Cross-Functional Collaboration

• Works closely with clinical development teams to embed quality expectations into study planning, startup, execution, and closeout
• Participates in project team meetings and cross-functional planning activities
• Works with Quality Compliance and Risk Management to support inspection readiness initiatives

Required experience & skills:

• Bachelor’s degree in life sciences or related discipline (advanced degree preferred)
• Minimum 8 years of related pharma/biotech Quality experience
• Strong knowledge of GCP regulations and regulatory expectations for late-stage clinical programs
• Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness

Preferred experience & skills:

• Experience building or scaling a GCP/GLP quality function in a small or emerging biotech
• CQA, RQAP-GCP, or ISO Lead Auditor certification
• Experience with computerized system validation for clinical and nonclinical systems

Base Salary Range:$175K - $210K

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Braveheart participates in the federal E‑Verify program to confirm employment authorization for all new hires.

To learn more about E-Verify please review this poster.