Braveheartbio
Associate Director, Quality (Clinical)
San Francisco, CA or Remote or Hybrid. Posted a month ago
The role
The Associate Director, Quality owns clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams. This person serves as a senior quality advisor across clinical programs and makes quality decisions within scope.
What you will do
- Applies clinical quality strategy for assigned studies and workstreams
- Serves as a trusted quality partner to clinical teams
- Serves as GCP subject matter expert for assigned programs
- Develops and executes clinical quality oversight plan
- Serves as the clinical QA representative on study teams
- 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 and drives investigations and CAPA to closure
- Leads GCP inspection readiness activities and serves as quality lead during health authority inspections
- Oversees TMF quality and inspection readiness
Required qualifications
- Bachelor’s degree in life sciences or related discipline
- 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
Nice to have
- Advanced degree
- 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
Benefits
- Annual bonus
- Equity
- Comprehensive benefits offering
Before you apply
- Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires
About the company
Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases.