Senior Manager, Corporate Quality Compliance

🕒 Setembro 25

🇺🇸 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

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Coordinate and lead or participate in Global Quality Compliance audits of corporate quality management systems, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers • Ensure completion, maintenance, and sustainability of role-specific audit training • Support preparation of annual audit plans • Assess compliance with applicable regulations and participate in action-plan assessments to correct deficiencies • Provide technical and organizational leadership to resolve site and multi-site compliance issues • Alert executive management to significant quality and compliance risks • Serve as a subject matter expert on global regulated requirements and inspectional commitments • Support domestic and international Regulatory Authority inspections • Represent Global Quality Compliance on cross-functional teams and collaborate with other departments • Ensure Amgen standards, strategies, and direction align with regulations and regulatory expectations • Support audit and inspection metrics • Support continual improvement initiatives, programs, and projects • Own or perform QA approval for DQMS Quality Event records for the GQC and Audits & Inspections network

🎯 Requisitos

• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, and Data Integrity • Certified Quality Auditor (CQA) or equivalent • Approximately 50% domestic and international travel • 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 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation • Auditing experience in internal audit, affiliate, CMO, contract laboratory, transportation/logistics/distribution/warehouse services • Knowledge of international regulations and standards • Detail-oriented • Organizational and multitasking skills

🏖️ Benefícios

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible • Career development opportunities • Work/life balance support