Senior QA Lead, Major Deviations Lifecycle & Compliance

Amgen SA; Juncos (PR); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Retirement & Savings Plan

Medical/Dental/Vision coverage

Stock incentives

Bonus program

Flexible work model

Job summary

Amgen seeks a Sr Mgr Quality Assurance to lead the Major Deviations Lifecycle Team across manufacturing, packaging, lab and support operations. You will drive investigations, CAPAs, and regulatory readiness, partnering with QA, QC, Manufacturing, Regulatory Affairs and Compliance to ensure product quality and patient safety.

The role requires advanced degrees and extensive quality experience, with people leadership responsibilities.

Qualifications

• Doctorate + 2+ years quality support experience.
• Master’s + 6+ years quality support experience.
• Bachelor’s + 8+ years quality support experience.
• 2+ years leadership/people management experience.

Responsibilities

• Lead and manage the Major Deviations Team and CAPAs.
• Oversee deviation investigations with scientific, technical, and regulatory rigor.
• Ensure deviations are initiated, investigated, approved, and closed on time.
• Drive root cause analyses and risk-based decision making.
• Support internal audits, regulatory inspections, and evidence-based improvements.

Skills

Leadership

Quality systems

Regulatory compliance

CAPA

Root cause analysis

Investigations

Quality audits

Education

Doctorate degree in Life Science or related

Master’s degree in Science/Engineering

Bachelor’s degree in Science

Tools

DQMS

Job description

Amgen seeks a Sr Mgr Quality Assurance to lead the Major Deviations Lifecycle Team across manufacturing, packaging, lab and support operations. You will drive investigations, CAPAs, and regulatory readiness, partnering with QA, QC, Manufacturing, Regulatory Affairs and Compliance to ensure product quality and patient safety.

The role requires advanced degrees and extensive quality experience, with people leadership responsibilities.