QA Leader: Major Deviations & Compliance

Amgen Inc. (IR); Juncos (PR); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Career development support

Job summary

Amgen Inc. (IR) seeks a Senior Manager of Quality Assurance for the Major Deviations Lifecycle team to lead investigations, CAPAs, and risk assessments across manufacturing, packaging, and QA operations.

The role ensures timely, compliant handling of significant quality events and partners with Regulatory Affairs and Compliance, Manufacturing, and Supply Chain. Ideal candidates have strong leadership, robust QA systems experience, and a proven track record in deviation management and inspection

Qualifications

• PhD with 2+ years quality support experience or
• MS with 6+ years quality support experience or
• BS with 8+ years quality support experience or
• HS diploma with 12+ years quality support experience

Responsibilities

• Lead the Major Deviations Team and manage investigations, root cause analyses, CAPAs, and regulatory activities.
• Ensure deviations are initiated, investigated, approved, and closed within quality timelines.
• Collaborate with cross-functional teams to identify systemic issues and implement CAPA actions.
• Support audits and inspections, ensuring inspection readiness and regulatory alignment.
• Drive continuous improvement and risk-based decision making across manufacturing, packaging, and labs.

Skills

Quality Assurance

Leadership

Investigations

CAPA

Regulatory compliance

Risk assessment

Education

Doctorate degree in Life Science

Master's degree in related field

Bachelor's degree in science

Tools

DQMS / data quality management system

eQMS / electronic quality management system

Job description

Amgen Inc. (IR) seeks a Senior Manager of Quality Assurance for the Major Deviations Lifecycle team to lead investigations, CAPAs, and risk assessments across manufacturing, packaging, and QA operations.

The role ensures timely, compliant handling of significant quality events and partners with Regulatory Affairs and Compliance, Manufacturing, and Supply Chain. Ideal candidates have strong leadership, robust QA systems experience, and a proven track record in deviation management and inspection