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Associate Director, Quality – Clinical
Braveheart Bio. Own clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams end to end .
Posted 10/5/2026full-timeSan Francisco • California • United StatesSenior💰 $175,000 - $210,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical quality oversight, GCP compliance, and risk management, with a strong focus on developing audit strategies and ensuring inspection readiness. Proven ability to lead quality initiatives and collaborate effectively with cross-functional teams in the pharma/biotech industry.
Highest-signal resume keywords
Clinical Quality OversightGCP ComplianceAudit Strategy DevelopmentInspection ReadinessRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Risk ManagementProtocol ReviewDeviation InvestigationRoot Cause AnalysisCAPA ManagementComputerized System ValidationGCP Regulations KnowledgeVendor OversightClinical QA RepresentationStudy Quality Oversight Plans
Soft Skills
LeadershipCollaborationCommunication
Tools & Technologies
EDC SystemsETMF SystemsIRT SystemsECOA Systems
Certifications & Qualifications
CQARQAP-GCPISO Lead Auditor
Industry Keywords
PharmaBiotechGxPICH E6(R3)21 CFR Part 11EU Annex 11ALCOA+
About the role
Key responsibilities & impact- Own clinical and nonclinical quality oversight for assigned studies, vendors, and workstreams end to end
- Serve as a senior quality advisor across clinical programs and primary quality contact for assigned vendors and CROs
- Direct contractors or junior staff
- Apply clinical quality strategy aligned with global regulatory requirements and risk-based quality principles
- Identify, assess, and mitigate quality risks
- Serve as GCP subject matter expert
- Develop and execute clinical quality oversight plans
- Serve as clinical QA representative from protocol development through study close-out
- Review protocols, monitoring plans, data management plans, and study documents for GCP compliance
- Oversee study quality risk management in line with ICH E6(R3)
- Review and trend protocol deviations; investigate significant quality events and potential serious breaches; drive CAPA to closure
- Lead GCP inspection readiness and serve as quality lead during health authority inspections
- Oversee TMF quality and inspection readiness
- Provide quality oversight of EDC, eTMF, IRT, and eCOA systems for 21 CFR Part 11, EU Annex 11, and ALCOA+ compliance
- Develop and maintain audit strategies and vendor oversight plans
- Lead deviation investigations, root cause analysis, and CAPA management
- Direct contracted auditors performing investigator site audits
- Collaborate with clinical development, Quality Compliance, and Risk Management teams
- Support broader GxP activities as business needs evolve
Requirements
What you’ll need- 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
- Experience building or scaling a GCP/GLP quality function in a small or emerging biotech (preferred)
- CQA, RQAP-GCP, or ISO Lead Auditor certification (preferred)
- Experience with computerized system validation for clinical and nonclinical systems (preferred)
Benefits
Comp & perks- Competitive total rewards package
- Annual bonus eligibility
- Equity eligibility
- Comprehensive benefits offering