Quality & Compliance Expert

Roche

Indianapolis, US
Base: $101,200 - $188,000; bonus/equity: discretio...
Onsite
Computer systems validation (csv)
Gxp, data privacy laws, and regulations
Regulatory standards (e.g., gmp, gcp)
As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle

Job Summary

  • As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle.
  • You will ensure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g., CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche's business.
  • The company culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are.

Matching Summary

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle.

Salary

Base: $101,200 - $188,000; Bonus/Equity: Discretionary annual bonus may be available; Benefits: Detailed at link provided

Skills & Requirements

Must-have

  • Computer Systems Validation (CSV)
  • GxP, Data privacy laws, and regulations
  • Regulatory standards (e.g., GMP, GCP)
  • Quality Oversight
  • Product roadmap and lifecycle management
  • Health regulatory frameworks (FDA, EMEA, ISO9001, ISO13485, PIC/s)
  • Risk and control frameworks

Nice-to-have

  • Lean-Agile Mindset
  • Progressive risk-taking
  • Executive presence
  • Strong business acumen
  • Ability to navigate ambiguity
  • Continuous learning of technology trends

Key Requirements

  • Bachelor’s degree in IT, Computer Science, Engineering, or equivalent
  • 7+ years of experience in IT, data science, quality, or related
  • Understanding of government guidelines and laws (NIST, HIPAA, GDPR, EU AI Act)

Work Rights

Not specified

Tailored Resume

Cover Letter