Associate Director, Development Quality – OSD
Core
Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners.
Role type
Senior IC development quality director (oral biopharmaceuticals)
Builds
Oral drug development programs for MASH treatment
Domain
Biopharmaceuticals / Oral therapeutics / MASH
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Development QA governance, risk-based judgment, cross-functional leadership, change management, quality risk management, vendor governance
Preferred skills
Pharmaceutical/biotech oral product development experience, external development network management, inspection support experience
Technologies
Veeva Vault Quality (eQMS)
Responsibilities
Own quality strategy, governance cadence, and risk register for assigned oral programs; Guide application of QMS processes (deviations/CAPA/change control); Oversee external vendors/CMOs and ensure governance; Maintain inspection-ready documentation and evidence packages
Seniority
Senior, hands-on IC