Quality Compliance, Senior Manager
Amgen
Full-time
Remote friendly (United States)
United States
Corporate Functions
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Role Summary
Quality Compliance, Senior Manager at Amgen. Lead global quality compliance audits and related tasks to support corporate and departmental goals, with focus on regulatory alignment, risk assessment, and continuous improvement in quality systems.
Responsibilities
- Coordinates, leads, or participates in Corporate Quality Compliance Audits of the Corporate Quality Management System, Amgen sites, contract facilities, affiliates, and critical service providers to assess regulatory compliance and identify top compliance risks.
- Assesses state of compliance with applicable regulations and leads or participates in action plan development to correct deficiencies.
- Implements risk assessments.
- Ensure completion, maintenance and sustainability of assigned training to support the audit process.
- Demonstrates knowledge of Amgen’s competencies across manufacturers, API/drug substance, drug product, combination products, medical devices, and laboratories.
- Provides leadership in identifying site and multi-site compliance issues from audit findings.
- Serves as subject matter expert on global regulated requirements and inspection commitments.
- Provides support for domestic and international Regulatory Authority Inspections when necessary.
- Provides technical support/compliance review of multi-site/global documents to resolve compliance issues as needed.
- Interacts with functional leads to align standards, strategies, and regulatory expectations.
- Alerts senior or executive management of significant quality and compliance risks.
- Supports audit and inspection metrics and continual improvement initiatives, programs, and projects.
Qualifications
- Basic Qualifications:
- Doctorate degree and 2 years of compliance experience OR
- Master’s degree and 4 years of compliance experience OR
- Bachelor’s degree and 6 years of compliance experience OR
- Associate’s degree and 10 years of compliance experience OR
- High school diploma / GED and 12 years of compliance experience
- Preferred Qualifications:
- Lead Auditor Certification
- Audit experience in DS/DP/FDP, Medical Device, Combination Product, API, and/or small molecule
- Strong verbal and written communication skills
- Domestic and international travel up to 50%
Skills
- Regulatory knowledge and inspection readiness
- Quality systems and risk assessment
- Audit leadership and stakeholder management
- Technical compliance review across multi-site/global documents
- Effective communication and collaboration across functions
Education
- As listed in Basic Qualifications above
Additional Requirements
- Travel up to 50% as needed