Senior Specialist, Digital & Data Quality

med-in.at

Base: $104,200.00 - $163,900.00; bonus/equity: ann...
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Computerized system validation (csv)
21 cfr part 11 compliance knowledge
Gxp regulatory requirements expertise
** The Senior Specialist, Digital & Data Quality position at med-in.at involves ensuring compliance with quality standards for GMP computerized systems in a regulated pharmaceutical manufacturing environment. The role requires collaboration with various stakeholders to oversee system lifecycle processes while promoting a culture of continuous improvement. **

Job Summary

  • The Senior Specialist will ensure compliance with company policies and regulatory expectations for all 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 med-in.at involves ensuring compliance with quality standards for GMP computerized systems in a regulated pharmaceutical manufacturing environment. The role requires collaboration with various stakeholders to oversee system lifecycle processes while promoting a culture of continuous improvement. **

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 compliance knowledge
  • GxP regulatory requirements expertise
  • 5 years regulated pharma experience
  • 3 years validated IT solutions experience

Nice-to-have

  • Six Sigma or PMP certification preferred
  • Multi-lingual capabilities preferred
  • Experience leading regulatory inspections
  • Strong business engagement skills
  • Mentoring 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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