Senior Manager, Corporate Quality Compliance

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $138.264 - $187.063 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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, as assigned • 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 when necessary • Serves as senior Global Quality Compliance representative on cross-functional teams and interacts with other departments in order to achieve goals • Interacts with other functional area leads to ensure that Amgen Standards, strategies, and direction are aligned with existing regulations and regulatory expectations • Provides support for audit and inspection metrics, as necessary • Supports Continual Improvement initiatives, programs, and projects

🎯 Requisitos

• 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 of 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

🏖️ Benefícios

• 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