Senior Supplier Quality Auditor

RayzeBio

Indianapolis, IN, US
Base: $96,148 - $116,508; bonus/equity: + incentiv...
Fully remote
7 years quality assurance experience
3 years auditing in gxp environment
Knowledge of fda ema ich regulations
The role involves leading the planning, execution, and reporting of supplier audits to ensure compliance with cGMP/GxP regulations

Job Summary

  • The role involves leading the planning, execution, and reporting of supplier audits to ensure compliance with cGMP/GxP regulations.
  • Candidates must have a minimum of 7 years of experience in quality assurance within the pharmaceutical or biotechnology industry.
  • The position offers competitive compensation ranging from $96,148 to $116,508 along with comprehensive health and wellbeing benefits.

Matching Summary

The role involves leading the planning, execution, and reporting of supplier audits to ensure compliance with cGMP/GxP regulations.

Salary

Base: $96,148 - $116,508; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), unlimited PTO options

Skills & Requirements

Must-have

  • 7 years quality assurance experience
  • 3 years auditing in GxP environment
  • Knowledge of FDA EMA ICH regulations
  • Experience with GMP GLP GCP domains
  • Ability to identify systemic risks

Nice-to-have

  • Strong analytical and report writing skills
  • Ability to utilize AI tools for productivity
  • Excellent stakeholder management skills
  • Continuous improvement initiative participation
  • Independent work and priority management

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 7 years QA/auditing experience
  • At least 3 years specific auditing experience
  • Domestic travel required up to 15%

Work Rights

Not specified

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