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Senior Manager, Corporate Quality Compliance
Amgen. 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 .
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- 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