Senior QA Lead, Major Deviations Lifecycle

Amgen; Juncos (PR); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Life & disability insurance

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Senior Manager of Quality Assurance to lead the Major Deviations Lifecycle Team, ensuring timely, compliant investigations and CAPAs across manufacturing, packaging, laboratory, and support operations.

The role partners with QA, QC, Manufacturing, Engineering, and Regulatory teams to drive robust investigations, continuous improvement, and inspection readiness for FDA/EMA expectations. Strong leadership and regulatory knowledge are essential.

Qualifications

• Doctorate or advanced degree with quality support experience.
• Master's or higher with quality support experience.
• Bachelor's with significant quality support experience.
• Associate's or High school with long-term quality experience.

Responsibilities

• Lead and manage the Major Deviations Team with coaching and resource planning.
• Oversee complex deviation investigations ensuring scientific and regulatory rigor.
• Ensure timely initiation, investigation, approval and closure of deviations within quality timelines.
• Lead root cause analyses and risk-based decision making for CAPAs.
• Maintain documentation in the digital quality management system (DQMS) and verify effectiveness.
• Escalate critical issues to site leadership and Quality Management.
• Collaborate cross-functionally to identify systemic issues and corrective actions.
• Monitor deviation trends and support audits and regulatory inspections.

Skills

Analytical thinking

Problem solving

Decision making

Communication skills

Presentation skills

Organization

Leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma/GED

Job description

Amgen is seeking a Senior Manager of Quality Assurance to lead the Major Deviations Lifecycle Team, ensuring timely, compliant investigations and CAPAs across manufacturing, packaging, laboratory, and support operations.

The role partners with QA, QC, Manufacturing, Engineering, and Regulatory teams to drive robust investigations, continuous improvement, and inspection readiness for FDA/EMA expectations. Strong leadership and regulatory knowledge are essential.