Director, Quality Assurance

Responsibilities

• Lead the quality team supporting drug substance manufacturing execution activities within a FleX Batch manufacturing facility.
• Build and lead a high-performing quality organization to support 24/7 manufacturing operations.
• Contribute to the development of the site Quality strategy and oversee GMP systems and operations.
• Provide quality expertise for project and operational design decisions and lead operational readiness activities.
• Lead and participate in Quality Risk Assessments.
• Recruit, coach, develop, and retain staff while ensuring an adaptable organizational structure.
• Drive continuous improvement in quality outputs and performance.
• Serve as the quality representative to regulatory authorities, corporate auditors, and third parties.
• Communicate significant quality, compliance, supply, and safety risks to management.

Requirements

• Bachelor's degree and 10 years of Quality/Manufacturing/Engineering experience, OR
• Master's degree and 8 years of Quality/Manufacturing/Engineering experience, OR
• Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience.
• At least 4 years of experience directly managing people and/or leading teams, projects, or programs.

Preferred Qualifications

• Bachelor's Degree in a Science field.
• 15+ years of experience in Quality within the biopharmaceutical or regulated manufacturing industry.
• Previous experience in Quality oversight of Biologics drug substance operations.
• Strong knowledge of cGMPs and experience interacting with Regulators.
• Proven experience supporting regulatory inspections and site audits.
• Demonstrated leadership of cross-functional teams within a manufacturing site.
• Experience driving operational excellence and continuous improvement initiatives.

Benefits

• Comprehensive employee benefits package including medical, dental, vision, life, and disability insurance.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients living with serious illnesses. Since 1980, Amgen has pioneered the biotech industry, focusing on therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease to deliver innovative medicines worldwide.