Senior Specialist, Digital & Data Quality

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Base: $104,200.00 - $163,900.00; bonus/equity: ann...
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5+ years regulated pharmaceutical experience
3+ years validated it solutions experience
21 cfr part 11 and gamp knowledge
** The Senior Specialist, Digital & Data Quality position at Merck focuses on ensuring the quality of GMP computerized systems across various manufacturing and laboratory settings. The role involves collaboration with various stakeholders to maintain compliance, drive continuous improvement, and support regulatory activities. **

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 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

Match Score: 75

** The Senior Specialist, Digital & Data Quality position at Merck focuses on ensuring the quality of GMP computerized systems across various manufacturing and laboratory settings. The role involves collaboration with various stakeholders to maintain compliance, drive continuous improvement, and support regulatory activities. **

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

  • 5+ years regulated pharmaceutical experience
  • 3+ years validated IT solutions experience
  • 21 CFR Part 11 and GAMP knowledge
  • Computerized System Validation (CSV) expertise
  • GMP compliance and data integrity skills

Nice-to-have

  • Six Sigma or PMP certification
  • Multi-lingual capabilities
  • Experience leading regulatory inspections
  • Project management with sense of urgency
  • Ability to mentor junior team members

Key Requirements

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

Work Rights

Not specified

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