Senior Manager Corporate Quality Compliance
Amgen
8 hours ago
Remote friendly (United States)
United States
Corporate Functions
Global Quality Compliance, Senior Manager
What You Will Do
- Coordinate and lead or participate in Global Quality Compliance audits of the Corporate Quality Management System, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers to assess compliance with applicable regulations and identify top compliance risks.
- Ensure completion, maintenance, and sustainability of role-specific training to support the audit process (including applying regulatory requirements, changes to regulations/guidelines/standards, and trends/expectations).
- Support preparation of annual audit plans (as assigned).
- Assess state of compliance with appropriate regulations and participate in assessment of action plans to correct deficiencies.
- Provide technical and organizational leadership to resolve site and multi-site compliance issues.
- Alert executive management of significant quality and compliance risks.
- Serve as subject matter expert on global regulated requirements and inspectional commitments (as applicable).
- Support domestic and international Regulatory Authority inspections (as necessary).
- Serve as senior representative on cross-functional teams (e.g., QMS, GPO, ALF, special task forces) and interact with other departments.
- Align Amgen Standards, strategies, and direction with existing regulations and regulatory expectations.
- Support audit and inspection metrics (as necessary).
- Support continual improvement initiatives, programs, and projects.
- 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: domestic and international approximately 50%.
Basic Qualifications
- Doctorate degree and 2 years of auditor experience OR Master’s degree and 6 years OR Bachelor’s degree and 8 years OR Associate’s degree and 10 years OR High school diploma/GED and 12 years.
- Plus a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation/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; strong organizational and multitask skills.
What You Can Expect (Benefits)
- Total Rewards Plan (based on eligibility): comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible remote/hybrid work (where possible).
Application Instructions
- Apply via careers.amgen.com.
- No application deadline; applications will be accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- Coordinate and lead or participate in Global Quality Compliance audits of the Corporate Quality Management System, Amgen sites, contract facilities, affiliates, critical service providers, suppliers, partners, and wholesalers to assess compliance with applicable regulations and identify top compliance risks.
- Ensure completion, maintenance, and sustainability of role-specific training to support the audit process (including applying regulatory requirements, changes to regulations/guidelines/standards, and trends/expectations).
- Support preparation of annual audit plans (as assigned).
- Assess state of compliance with appropriate regulations and participate in assessment of action plans to correct deficiencies.
- Provide technical and organizational leadership to resolve site and multi-site compliance issues.
- Alert executive management of significant quality and compliance risks.
- Serve as subject matter expert on global regulated requirements and inspectional commitments (as applicable).
- Support domestic and international Regulatory Authority inspections (as necessary).
- Serve as senior representative on cross-functional teams (e.g., QMS, GPO, ALF, special task forces) and interact with other departments.
- Align Amgen Standards, strategies, and direction with existing regulations and regulatory expectations.
- Support audit and inspection metrics (as necessary).
- Support continual improvement initiatives, programs, and projects.
- 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: domestic and international approximately 50%.
Basic Qualifications
- Doctorate degree and 2 years of auditor experience OR Master’s degree and 6 years OR Bachelor’s degree and 8 years OR Associate’s degree and 10 years OR High school diploma/GED and 12 years.
- Plus a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation/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; strong organizational and multitask skills.
What You Can Expect (Benefits)
- Total Rewards Plan (based on eligibility): comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible remote/hybrid work (where possible).
Application Instructions
- Apply via careers.amgen.com.
- No application deadline; applications will be accepted until a sufficient number are received or a candidate is selected.