Director, Quality Assurance
Core
Architecting quality culture and regulatory standards for AI-driven drug discovery and clinical-stage operations.
Role type
Director, Quality Assurance (Player-coach)
Builds
Clinical Quality Management Systems (QMS), vendor audit frameworks, and AI/ML model validation protocols for clinical trials.
Domain
Biotechnology / Pharmaceutical / Clinical Research / AI/ML in Drug Discovery
Deliverable
production ML models | product features | dashboards & analysis
Required skills
GXP compliance (GLP, GCP, GMP), Quality Management System (QMS) design, vendor audit leadership, Computer System Validation, regulatory strategy, data lineage governance, risk management
Preferred skills
Experience moving biotech through clinical entry, building processes from scratch, partnering with data science teams
Technologies
Cloud-based compute environments, data pipelines, AI/ML model validation frameworks
Responsibilities
Design and implement a robust Quality Management System (QMS) including Document Control, Deviations, CAPAs, and Change Control; Author core SOPs and develop training programs; Lead quality lifecycle for CROs/CMOs/CDMOs and perform audits; Partner with Compute teams to validate AI/ML models for patient selection and biomarker discovery; Ensure end-to-end data traceability from raw biological data to clinical insights; Establish quality systems for research operations and business risk oversight.
Seniority
Director, strategic leadership with hands-on execution