Quality Compliance Manager

4 days ago

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Amgen

WebsiteLinkedInAll Job Openings

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

Description

• Provide quality support for developing and implementing a risk-based quality assurance strategy • Maintain integrity of Amgen's research data • Support GLP compliance oversight • Plan, conduct and report on risk-based R&D audits • Review, negotiate and approve responses to R&D audit findings • Manage deliverables and provide data and recommendations regarding quality • Support regional expertise for quality and compliance • Actively seek and implement innovative quality oversight methodologies

Requirements

• Doctorate degree OR Master’s degree and 2 years of Quality/Compliance/Process Management experience OR • Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR • Associate’s degree and 8 years of Quality/Compliance/Process Management experience OR • High school diploma / GED and 10 years of Quality/Compliance/Process Management experience • Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry • Experience with Quality Oversight of Nonclinical Trials, including auditing GLP phases • Oversight of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise • Detailed understanding of R&D activities and Global Regulations • Knowledge of the Regulatory Submission and Inspection Management procedures • Excellent verbal and written communication skills • Strong analytical, critical-thinking and decision-making abilities

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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible