Digital & Data Quality (DDQ) GMP AI Compliance Director
USA - Pennsylvania - West Point, United States
R
USD 173K-272K Executive-level Full Time
Tasks
- Benchmark industry peers through external engagements
- Coordinate quality oversight to maintain validated state and ensure output reliability and explainability
- Define standards for GMP and GDP AI tools data management and quality risk management
- Develop validation and monitoring policies and procedures for AI tools
- Experiment with AI technologies for DDQ operations
- Lead DDQ resource planning hiring training and performance coaching
- Lead DDQ strategy continuous improvement and team development
- Manage escalations
- Monitor AI regulatory trends for GMP and GDP
- Partner with manufacturing research and IT to standardize AI solutions
- Perform quality input for GMP classification risk assessment validation and monitoring of AI tools
Perks/Benefits
- 401k
- Compassionate days
- Dental insurance
- Hybrid work
- Medical insurance
- Paid Holidays
- Retirement benefits
- Sick days
- Vacation
- Vision insurance
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | AI Governance | Annex 11 | Annex 15 | Artificial Intelligence | CFR Part 11 | Cause analysis | Change Management | Computerized systems | Cross-Functional Collaboration | Cross-functional | Data Integrity | Data Management | Data Quality | Data Retention | EU Annex 11 | EU Annex 15 | EU regulations | Explainability | FDA Regulations | Facilitation | Functional collaboration | GAMP | GMP Compliance | Human-in-the-loop | ICH Guidelines | Lean Six Sigma | Model Monitoring | Model Performance Assessment | Model performance | Monitoring | Negotiation | Part 11 | Performance Assessment | Project Management | Quality Risk Management | Risk Management | Root Cause Analysis | Root cause | Six Sigma | The Loop | Training | Validation | Vendor Assessment | WHO Guidelines
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
Cities
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