Manager Quality Assurance - Night Shift

Amgen Australia Pty Ltd

North Carolina, US
Base: 125,141.00 usd - 154,672.00 usd; bonus/equit...
Onsite (night shift)
Gmp manufacturing oversight
Quality systems integration
Change management
Amgen Australia Pty Ltd is seeking a Manager of Quality Assurance for their North Carolina facility, specifically for the night shift. The role involves overseeing the Quality Assurance team during the startup and ongoing operations of a new drug manufacturing facility, ensuring compliance with Good Manufacturing Practices (GMP)

Job Summary

  • In this vital role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing.
  • The Manager Quality Assurance will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective, efficient and compliant manner.
  • Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

Matching Summary

Match Score: 85

Amgen Australia Pty Ltd is seeking a Manager of Quality Assurance for their North Carolina facility, specifically for the night shift. The role involves overseeing the Quality Assurance team during the startup and ongoing operations of a new drug manufacturing facility, ensuring compliance with Good Manufacturing Practices (GMP).

Salary

Base: 125,141.00 USD - 154,672.00 USD; Bonus/Equity: Discretionary annual bonus program, Stock-based long-term incentives; Benefits: Comprehensive employee benefits package, Retirement and Savings Plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts

Skills & Requirements

Must-have

  • GMP Manufacturing oversight
  • Quality Systems integration
  • Change management
  • cGMP and GDP compliance
  • Inspection readiness

Nice-to-have

  • Collaborative and innovative culture
  • Passion for challenges
  • Science-based approach
  • Patient-focused mission

Key Requirements

  • High school diploma / GED and 12 years of Quality Assurance experience
  • Associate’s degree and 10 years of Quality Assurance experience
  • Bachelor’s degree and 5 years of Quality Assurance experience
  • Master’s degree and 3 years of Quality Assurance experience
  • Doctorate degree and 3 years of Quality Assurance experience
  • Experience directly managing people or leading teams

Work Rights

Not specified

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