Senior Manager Corporate Quality Compliance

Global Quality Compliance, Senior Manager

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 to assess compliance with all applicable regulations and to identify top compliance risks.
• 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, as applicable.
• 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.
• Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

Additional Requirements

• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
• Certified Quality Auditor (CQA) or equivalent
• Travel: Domestic and International Approximately 50%

Basic Qualifications

• 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
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Preferred Qualifications

• Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/warehouse services, 50% international travel requirement
• Knowledge of international regulations and standards
• Auditing certification preferred
• Detail oriented
• Organizational and multi task skills