Global Quality Compliance Senior Manager

Regulatory Jobs; United States; Hybrid; USD 138,000 - 187,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Remote and hybrid work arrangements

Job summary

Amgen seeks a Senior Manager, Global Quality Compliance to lead audits and regulatory readiness across sites, affiliates and suppliers. You will drive QA approvals, training programs, and compliance metrics, while guiding cross-functional teams and informing executives of risks.

Travel approx. 50% domestically and internationally; requires advanced degrees and a CQ auditor background. The role offers a total rewards plan and flexible work arrangements.

Qualifications

• Doctorate or higher with significant auditing experience.
• Master's/ Bachelor's with auditor experience and relevant certifications considered.
• Experience with global regulatory inspections and quality systems.

Responsibilities

• Execute Global Quality Compliance tasks and projects to meet corporate goals.
• Coordinate and lead audits of the Corporate Quality Management System and sites/affiliates.
• Maintain training per role to support audit processes and regulatory requirements.
• Support annual audit plans and assess compliance actions.
• Provide leadership to resolve site and multi-site compliance issues and alert management to risks.
• Serve as SME on global regulatory requirements and inspections.

Skills

Aseptic Processing

Drug Product

Drug Substance

Combination Products

Data Integrity

Auditing

Leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

Quality Management System (QMS)

Job description

Amgen seeks a Senior Manager, Global Quality Compliance to lead audits and regulatory readiness across sites, affiliates and suppliers. You will drive QA approvals, training programs, and compliance metrics, while guiding cross-functional teams and informing executives of risks.

Travel approx. 50% domestically and internationally; requires advanced degrees and a CQ auditor background. The role offers a total rewards plan and flexible work arrangements.