Quality And Compliance Manager - Regulated Software Systems

Ecolab Pty Ltd

Multiple Locations
Base: $107,600.00 - $161,500.00; bonus/equity: eli...
Gxp and fda 21 cfr part 11 compliance
Computer system validation (csv) leadership
Quality management system (qms) implementation
This role leads quality assurance and regulatory compliance efforts for a new cloud-native software platform in a highly regulated industry

Job Summary

  • This role leads quality assurance and regulatory compliance efforts for a new cloud-native software platform in a highly regulated industry.
  • The Quality & Compliance Manager will define and enforce quality standards, oversee validation activities, and ensure systems are maintained in a state of control.
  • Ecolab offers comprehensive and market-competitive benefits to meet the needs of associates and their families.

Matching Summary

This role leads quality assurance and regulatory compliance efforts for a new cloud-native software platform in a highly regulated industry.

Salary

Base: $107,600.00 - $161,500.00; Bonus/Equity: Eligible for annual bonus based on performance; Benefits: Comprehensive and market-competitive benefits

Skills & Requirements

Must-have

  • GxP and FDA 21 CFR Part 11 compliance
  • Computer System Validation (CSV) leadership
  • Quality management system (QMS) implementation
  • Validation planning and risk management
  • Cloud-native software platform validation
  • Software development lifecycle (SDLC) quality integration

Nice-to-have

  • Experience with GAMP 5 and ISO 13485
  • Familiarity with Agile and DevOps methodologies
  • Cloud platform knowledge (Azure, AWS, GCP)
  • Support for regulatory inspections and audits
  • Knowledge of AI/ML validation in regulated environments
  • Strong communication and collaboration skills

Key Requirements

  • Bachelor’s degree in relevant field
  • 8 years software quality assurance experience
  • 3 years in regulated industry
  • Deep understanding of GxP and FDA 21 CFR Part 11
  • Experience with cloud-based SaaS validation
  • No immigration sponsorship available

Work Rights

Not specified

Tailored Resume

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