Senior Manager, Corporate Quality Compliance

🕒 il y a 7 jours

🇺🇸 États-Unis – Télétravail

💵 $138 264 - $187 063 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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