Senior Specialist, Digital & Data Quality

medhunter.de

Base: $104,200.00 - $163,900.00; bonus/equity: ann...
Hybrid
Computerized system validation (csv)
Gxp regulatory compliance
21 cfr part 11 knowledge
The Senior Specialist is responsible for the quality aspects of GMP computerized systems to ensure compliance with company policies and regulatory expectations

Job Summary

  • The Senior Specialist is responsible for the quality aspects of GMP computerized systems to ensure compliance with company policies and regulatory expectations.
  • This role involves providing independent quality approval of key qualification documentation and supporting regulatory inspection activities across global sites.
  • The position offers a comprehensive benefits package including medical, dental, vision, retirement plans, and an annual bonus eligibility.

Matching Summary

The Senior Specialist is responsible for the quality aspects of GMP computerized systems to ensure compliance with company policies and regulatory expectations.

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)
  • GxP Regulatory Compliance
  • 21 CFR Part 11 Knowledge
  • Data Integrity Principles
  • Regulatory Inspection Support
  • Change Control Management

Nice-to-have

  • Six Sigma Certification
  • Project Management PMP
  • Multi-lingual Capabilities
  • Continuous Improvement Culture
  • Cross-functional Collaboration
  • Mentoring Junior Staff

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 computerized system validation principles
  • Experience with FDA/EU/ICH regulations and 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter