Senior Specialist, Digital & Data Quality

Merck & Co., Inc.

Base: $104,200.00 - $163,900.00; bonus/equity: ann...
Hybrid
Computerized system validation csv
21 cfr part 11 regulatory compliance
Gxp computerized system lifecycle management
The Senior Specialist is responsible for ensuring the quality aspects of GMP computerized systems to protect product quality and patient safety

Job Summary

  • The Senior Specialist is responsible for ensuring the quality aspects of GMP computerized systems to protect product quality and patient safety.
  • This role requires providing independent quality approval for key qualification documentation and facilitating continuous improvement across the system lifecycle.
  • The position offers a competitive salary range of $104,200.00 - $163,900.00 along with comprehensive benefits including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

The Senior Specialist is responsible for ensuring the quality aspects of GMP computerized systems to protect product quality and patient safety.

Salary

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

Skills & Requirements

Must-have

  • Computerized System Validation CSV
  • 21 CFR Part 11 regulatory compliance
  • GxP computerized system lifecycle management
  • Data integrity ALCOA principles
  • Regulatory inspection support experience

Nice-to-have

  • Six Sigma or PMP certification
  • Multi-lingual capabilities
  • Cross-functional collaboration skills
  • Mentoring junior team members
  • Continuous improvement culture promotion

Key Requirements

  • Bachelor's degree in Science, IT, or Engineering
  • Minimum 5 years in regulated pharmaceutical industry
  • At least 3 years in validated IT solutions or application support
  • Extensive knowledge of FDA/EU/ICH regulations
  • Hands-on experience with automated manufacturing and lab systems

Work Rights

Not specified

Tailored Resume

Cover Letter