This pivotal leadership opportunity involves shaping how high-quality medicines are delivered at scale through rigorous qualification standards
Job Summary
This pivotal leadership opportunity involves shaping how high-quality medicines are delivered at scale through rigorous qualification standards.
The role requires leading a high-performing team to ensure equipment, utilities, and computerized systems meet the highest regulatory compliance levels.
Compensation includes a performance-based cash incentive, potential annual equity awards, and a comprehensive benefits package with health and 401(k) matching.
Matching Summary
This pivotal leadership opportunity involves shaping how high-quality medicines are delivered at scale through rigorous qualification standards.
Salary
Base: $114,100 - $211,900 per year; Bonus/Equity: Performance-based cash incentive and annual equity eligibility; Benefits: Health, life, disability, 401(k) match, and generous time off
Skills & Requirements
Must-have
7 years engineering validation experience
5 years people leadership experience
Qualify equipment and computerized systems
FDA Title 21 CFR Parts 11, 210, 211 knowledge
ICH Q8, Q9, Q10 guideline understanding
Nice-to-have
Experience supporting regulatory inspections
Continuous improvement initiative implementation
Cost optimization in validation programs
Risk-based decision making culture
Proactive inspection readiness programs
Key Requirements
Bachelor's degree in engineering or science
Minimum 7 years pharmaceutical manufacturing experience