Director of Audit, Supplier Quality, & Applied AI Architecture
Tasks
- Assess impact of regulatory changes on QMS
- Build and lead internal audit and supplier quality team
- Conduct internal audits for QMS effectiveness
- Define and govern applied AI within regulated processes
- Define and monitor quality and audit KPIs
- Develop risk based internal audit strategy
- Ensure audit findings closure with CAPA
- Establish regulatory intelligence capability
- Establish standardized AI enabled review framework
- Lead AI system validation and controlled implementation
- Lead external audit readiness and execution
- Lead supplier quality program
- Manage FDA inspections and responses
- Manage notified body audits
- Manage supplier CAPA and escalations
- Monitor AI performance feedback loops
- Monitor supplier performance scorecards
- Oversee supplier audits
- Perform supplier qualification and onboarding
- Provide executive level audit reporting
- Report metrics to executive leadership and management review
- Translate regulations into policies and procedures
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR part 820 | AI Governance | AI Validation | Audit Readiness | CAPA | CFR Part 820 | Data analytics | EU MDR | FDA QMSR | Gap assessment | ISO 13485 | ISO 14971 | ISO 19011 | MDSAP | Management System | Mock Audits | Part 820 | Quality Management System | Quality management | Regulatory Compliance | Regulatory Intelligence | Risk Based Auditing | Risk Management | Risk-based | Supplier Quality | Supplier auditing
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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