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
- Provides quality support across broader GxP activities as business needs evolve
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.
