Quality and Compliance Regulated Software Systems
Core
Lead quality assurance and regulatory compliance for a new cloud-native software platform in a highly regulated industry, ensuring SDLC and deployments meet GxP and FDA 21 CFR Part 11.
Role type
Senior Quality & Compliance Manager
Builds
Cloud-native software platforms for regulated industries
Domain
Life Sciences / Medical Devices / Healthcare / Regulated Software
Deliverable
production ML models
Required skills
Computer System Validation (CSV), GxP, FDA 21 CFR Part 11, GAMP 5, risk management, change control, validation planning, audit trail implementation, electronic signatures, data integrity, SDLC integration, documentation review, QMS establishment
Preferred skills
GAMP 5, ISO 13485, cloud platforms (Azure/AWS/GCP), regulatory inspection support, AI/ML system validation
Technologies
Azure, AWS, GCP
Responsibilities
Define and implement quality/compliance strategy; Lead CSV process (plans, protocols, traceability); Embed compliance into SDLC; Review design and requirement documents; Oversee audit trails and access controls; Coordinate with external partners; Support internal/external audits; Establish and maintain QMS; Provide training on best practices
Seniority
Senior, hands-on IC