Manager Pqa

Amgen Australia Pty Ltd

Base: $125,141.00 - $154,672.00 usd; bonus/equity:...
Lead and develop quality staff across shifts
Ensure compliance with cgmp and gdp regulations
Oversee deviations, capas, and change controls
The role involves leading quality performance and providing strategic oversight across manufacturing and quality systems to ensure patient safety

Job Summary

  • The role involves leading quality performance and providing strategic oversight across manufacturing and quality systems to ensure patient safety.
  • Candidates must have experience directly managing people and possess deep knowledge of cGMP, GDP, and regulatory expectations within a biotech or pharma environment.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, and stock-based long-term incentives.

Matching Summary

The role involves leading quality performance and providing strategic oversight across manufacturing and quality systems to ensure patient safety.

Salary

Base: $125,141.00 - $154,672.00 USD; Bonus/Equity: Discretionary annual bonus program; Benefits: Comprehensive employee benefits package including retirement and health coverage

Skills & Requirements

Must-have

  • Lead and develop Quality staff across shifts
  • Ensure compliance with cGMP and GDP regulations
  • Oversee deviations, CAPAs, and change controls
  • Manage quality risks and audit readiness
  • Drive continuous improvement initiatives

Nice-to-have

  • Passion for serving patients in serious illnesses
  • Ability to lead in a shift-based operation
  • Strong cross-functional collaboration skills
  • Proactive culture of accountability and compliance
  • Excellent communication and decision-making abilities

Key Requirements

  • Doctorate OR Master's + 3 years OR Bachelor's + 5 years OR Associate's + 10 years OR High School + 12 years quality experience
  • Direct people management or leadership experience required
  • Experience in GMP-regulated environment (biotech/pharma preferred)
  • Prior leadership or people management experience strongly preferred

Work Rights

Not specified

Tailored Resume

Cover Letter