Director, Quality Assurance (Bioservices)
Core
Implementing and maintaining quality systems for regulated diagnostic and companion diagnostic product portfolios, ensuring compliance with global standards and regulations.
Role type
Director, Quality Assurance (Bioservices)
Builds
Regulated diagnostic and companion diagnostic products
Domain
Life Sciences / Medical Devices / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global quality system management, Regulatory compliance (FDA, ISO, CLIA, CAP), Process improvement, Team leadership, Risk management, Validation planning, Budget management, Training coordination, Documentation authoring, External audit liaison
Preferred skills
Experience with medical device pre- and post-market activities, Relationship building with regulators and clients, Fluency in English
Technologies
MS Office, QMS electronic documentation systems, Validation protocols
Responsibilities
Plan and direct global quality and compliance functions, Provide oversight to site-specific quality leadership, Lead process improvement initiatives, Update company leadership on quality system status, Collaborate with cross-functional operational staff, Support FDA QSR, IVDD/IVDR, ISO 13485, and ISO 15189 compliance, Release commercial diagnostic products and results, Support post-market surveillance, Lead pre-market design control and risk management, Host external regulatory agency and client assessments, Coordinate training and budget schedules, Manage validation protocols and CAPA systems
Seniority
Director, strategic oversight & global team leadership
