Senior Manager, Corporate Quality Compliance

🔥 4 hours ago

🇺🇸 United States – Remote

💵 $138.3k - $187.1k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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