The Digital & Data Quality GMP AI Compliance Director role at Merck involves overseeing the implementation of AI-based tools in GMP operations, ensuring compliance with regulatory standards. The position requires extensive experience in the pharmaceutical industry and offers a hybrid work model with competitive compensation and benefits
Job Summary
Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations.
Partner with relevant stakeholders across our manufacturing division, our research & development division, and IT to develop common frameworks and champion use of common solutions across the divisions.
The salary range for this role is $173,200.00 - $272,600.00.
Matching Summary
Match Score: 85
The Digital & Data Quality GMP AI Compliance Director role at Merck involves overseeing the implementation of AI-based tools in GMP operations, ensuring compliance with regulatory standards. The position requires extensive experience in the pharmaceutical industry and offers a hybrid work model with competitive compensation and benefits.
Salary
Base: $173,200.00 - $272,600.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, compassionate and sick days
Skills & Requirements
Must-have
GMP/GDP AI compliance
Data management and quality
Regulatory trends in AI
Validation of AI tools
Quality risk management
Nice-to-have
Collaborative leadership style
External industry engagement
Experimentation with AI technologies
Lean Six Sigma certification
Project management certification
Key Requirements
12 years global and site experience
Bachelor's degree in Science, IT, or Engineering
Expert knowledge of FDA/EU/ICH/WHO regulations
Understanding of AI technologies and model monitoring