Senior Manager Corporate Quality Compliance
Amgen
June 24, 2026
Remote friendly (United States)
United States
Corporate Functions
Global Quality Compliance, Senior Manager
What You Will Do
- Coordinate, lead, and/or participate in Global Quality Compliance audits of the Corporate QMS, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers to assess regulatory compliance and identify top compliance risks.
- Ensure role-based training is completed, maintained, and sustained to support the audit process, including understanding regulatory changes, guidelines/standards, trends, and expectations.
- Support preparation of annual audit plans (as assigned).
- Assess compliance status; participate in action plan assessment to correct deficiencies.
- Provide technical/organizational leadership to resolve site and multi-site compliance issues.
- Alert executive management of significant quality and compliance risks.
- Serve as a subject matter expert on global regulated requirements and inspectional commitments (as applicable).
- Support domestic and international Regulatory Authority inspections (as necessary).
- Represent Global Quality Compliance on cross-functional teams and align Amgen standards/strategy with regulations and expectations.
- Support audit/inspection metrics and Continual Improvement initiatives.
- Own or perform QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).
Additional Requirements / Skills
- Experience with aseptic processing, drug product, drug substance, combination products, and data integrity.
- Certified Quality Auditor (CQA) or equivalent.
- Travel: ~50% domestic and international.
Basic Qualifications
- Doctorate + 2 years audit experience OR Master’s + 6 OR Bachelor’s + 8 OR Associate’s + 10 OR HS/GED + 12.
- Minimum 2 years directly managing people and/or leading teams/projects/programs/resources (may run concurrently with audit experience).
Preferred Qualifications
- Auditing experience (internal audit, affiliate, CMO, contract lab, transportation/logistics/distribution/warehouse).
- ~50% international travel; knowledge of international regulations/standards.
- Auditing certification preferred; detail oriented; organizational and multitask skills.
Benefits (as stated)
- Employee benefits package: retirement/savings plan, group medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); stock-based long-term incentives; time-off; remote/hybrid (where possible).
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient number/selection.
What You Will Do
- Coordinate, lead, and/or participate in Global Quality Compliance audits of the Corporate QMS, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers to assess regulatory compliance and identify top compliance risks.
- Ensure role-based training is completed, maintained, and sustained to support the audit process, including understanding regulatory changes, guidelines/standards, trends, and expectations.
- Support preparation of annual audit plans (as assigned).
- Assess compliance status; participate in action plan assessment to correct deficiencies.
- Provide technical/organizational leadership to resolve site and multi-site compliance issues.
- Alert executive management of significant quality and compliance risks.
- Serve as a subject matter expert on global regulated requirements and inspectional commitments (as applicable).
- Support domestic and international Regulatory Authority inspections (as necessary).
- Represent Global Quality Compliance on cross-functional teams and align Amgen standards/strategy with regulations and expectations.
- Support audit/inspection metrics and Continual Improvement initiatives.
- Own or perform QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).
Additional Requirements / Skills
- Experience with aseptic processing, drug product, drug substance, combination products, and data integrity.
- Certified Quality Auditor (CQA) or equivalent.
- Travel: ~50% domestic and international.
Basic Qualifications
- Doctorate + 2 years audit experience OR Master’s + 6 OR Bachelor’s + 8 OR Associate’s + 10 OR HS/GED + 12.
- Minimum 2 years directly managing people and/or leading teams/projects/programs/resources (may run concurrently with audit experience).
Preferred Qualifications
- Auditing experience (internal audit, affiliate, CMO, contract lab, transportation/logistics/distribution/warehouse).
- ~50% international travel; knowledge of international regulations/standards.
- Auditing certification preferred; detail oriented; organizational and multitask skills.
Benefits (as stated)
- Employee benefits package: retirement/savings plan, group medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); stock-based long-term incentives; time-off; remote/hybrid (where possible).
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient number/selection.