Quality Assurance Manager - Remote

Overview

As a Quality Assurance Manager at Amgen, you will play a crucial role in overseeing Quality and Compliance at contract manufacturing/testing sites, ensuring adherence to quality standards and regulations while supporting the mission of serving patients.

In Short

• Lead Quality and Compliance oversight for contract manufacturing/testing sites.
• Collaborate with cross-functional external supply teams.
• Negotiate and ensure adherence to Quality Agreements.
• Review and approve quality documentation and records.
• Support audits and inspections, ensuring inspection readiness.
• Identify and mitigate risks at supplier sites.
• Perform batch disposition activities for lot release.
• Occasional travel may be required.
• Work in a collaborative and innovative culture.
• Transform your career while making a lasting impact on patients' lives.

Requirements

• Doctorate degree or equivalent experience in quality/manufacturing.
• 8+ years of experience in the biotech or pharmaceutical industry preferred.
• Strong project management and problem-solving skills.
• Experience with analytical testing and regulatory activities.
• Ability to lead cross-functional teams and communicate effectively.
• Skilled in risk-based decision-making approaches.
• Experience in a matrixed team environment.
• Ability to influence senior partners and manage timelines.
• Familiarity with PM tools and methodologies.
• Experience with small molecules and manufacturing facilities is a plus.

Benefits

• Competitive benefits package including health and welfare plans.
• Retirement and Savings Plan with generous contributions.
• Flexible work models including remote and hybrid options.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Collaborative and inclusive work culture.
• Support for professional and personal growth.
• Commitment to diversity and equal opportunity.