Quality Assurance Manager

BAXTER HEALTHCARE PTY AUS

$116,480 - $160,160 annually; management incentive...
Ensure compliance with quality manual
Resolve product quality issues
Review batch records
Lead and manage the Quality Assurance organization to ensure compliance with the Quality Manual, Health Canada, FDA, ISO, Corporate requirements

Job Summary

  • Lead and manage the Quality Assurance organization to ensure compliance with the Quality Manual, Health Canada, FDA, ISO, Corporate requirements.
  • Provide frontline daily leadership, mentoring, and technical decision-making to resolve product quality issues.
  • Partner cross-functionally (Operations, Engineering, Supply Chain, Regulatory Affairs, Legal, etc.) to implement quality improvement initiatives and ensure alignment to site and corporate objectives.

Matching Summary

Lead and manage the Quality Assurance organization to ensure compliance with the Quality Manual, Health Canada, FDA, ISO, Corporate requirements.

Salary

$116,480 - $160,160 annually; Management Incentive Compensation Plan; Not specified

Skills & Requirements

Must-have

  • Ensure compliance with Quality Manual
  • Resolve product quality issues
  • Review batch records
  • Product disposition/release decision-making
  • Investigate quality/compliance events
  • Support internal and external audits

Nice-to-have

  • Creative problem-solving
  • Detail-oriented approach
  • Collaborative team player
  • Adaptable to changing work

Key Requirements

  • Bachelor’s degree in a relevant scientific field
  • 10 years of experience in quality assurance
  • 5-7 years’ experience managing people
  • In-depth knowledge of cGMP, ICH guidelines
  • Experience with quality management software tools

Work Rights

Not specified

Tailored Resume

Cover Letter