Job Summary

• The Senior Specialist will ensure compliance with company policies and regulatory expectations for GMP computerized systems across manufacturing, packaging, and laboratories.
• This role requires independent quality approval of key validation documentation and driving the resolution of regulatory non-conformances for GxP systems.
• The successful candidate will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

Salary

Base: $104,200.00 - $163,900.00; Bonus/Equity: Annual bonus and long-term incentive available; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Key Requirements

• Bachelor's degree in Science, IT, or Engineering
• Minimum 5 years in regulated pharmaceutical manufacturing
• At least 3 years in validated IT solutions or application support
• Extensive knowledge of FDA/EU/ICH regulations
• Experience in Quality and Compliance roles in GMP environment

Work Rights