Senior Manager – Corporate Quality Compliance

Amgen

Senior Manager managing Global Quality Compliance tasks and projects at biotech leader Amgen. Leading audits and ensuring compliance with global regulations

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $138,264 - $187,064 per yearWebsite

About the role

Key responsibilities & impact

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals
Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers
Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process
Supports preparation of the annual audit plans
Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies
Provides technical and organizational leadership toward resolving site and multi-site compliance issues
Alerts executive management of significant quality, and compliance risks
Serves as subject matter expert on global regulated requirements and inspectional commitments
Provides support for domestic and international Regulatory Authority Inspections
Serves as senior Global Quality Compliance representative on cross-functional teams
Interacts with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectation s
Supports Continual Improvement initiatives, programs, and projects.
Owns or performs QA approval for DQMS Quality Event records

Requirements

What you’ll need

Doctorate degree and 2 years of auditor experience OR Master’s degree and 6 years of auditor experience OR Bachelor’s degree and 8 years of auditor experience OR Associate’s degree and 10 years of auditor experience OR High school diploma / GED and 12 years of auditor experience
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/warehouse services
Knowledge of international regulations and standards
Auditing certification preferred
Detail oriented
Organizational and multi task skills

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

auditingAseptic ProcessingDrug ProductDrug SubstanceCombination ProductsData Integrityinternal auditaffiliate auditCMO auditContract laboratory audit

Soft Skills

detail orientedorganizational skillsmulti-taskingleadershipproject managementcommunicationtechnical leadershipproblem solvingcollaborationrisk management

Certifications

auditing certification