Senior Specialist, Digital & Data Quality

MOBS Lab

Base: $104,200.00 - $163,900.00; bonus/equity: ann...
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Computerized system validation (csv)
Gxp regulatory compliance
21 cfr part 11 knowledge
** MOBS Lab is seeking a Senior Specialist in Digital & Data Quality to ensure the quality and compliance of GMP computerized systems used in pharmaceutical manufacturing. The ideal candidate should have extensive experience in regulated environments, particularly in IT solutions and quality assurance processes. **

Job Summary

  • The Senior Specialist ensures quality aspects of GMP computerized systems to protect product quality and patient safety across the system lifecycle.
  • This role requires independent quality approval of key validation documentation including protocols, specifications, and reports to meet company standards and regulations.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 75

** MOBS Lab is seeking a Senior Specialist in Digital & Data Quality to ensure the quality and compliance of GMP computerized systems used in pharmaceutical manufacturing. The ideal candidate should have extensive experience in regulated environments, particularly in IT solutions and quality assurance processes. **

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

Must-have

  • Computerized System Validation (CSV)
  • GxP Regulatory Compliance
  • 21 CFR Part 11 Knowledge
  • Data Integrity Principles
  • Quality Assurance in Pharma
  • Regulatory Inspection Support

Nice-to-have

  • Six Sigma or PMP Certification
  • Multi-lingual Capabilities
  • Cross-functional Collaboration Skills
  • Mentoring Junior Team Members
  • Continuous Improvement Culture

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/laboratory systems

Work Rights

Not specified

Tailored Resume

Cover Letter