Amgen Inc. is hiring a Quality Compliance, Senior Manager

Amgen is hiring a Quality Compliance Senior Manager to drive our Global Quality Compliance Audit program and related projects. In this role, you will coordinate and lead audits, assess compliance with regulations, and implement risk assessments to achieve corporate and departmental goals. You will serve as a key expert on global regulated requirements within our collaborative and science-based culture.

What You'll Do

• Coordinate, lead, or participate in Corporate Quality Compliance Audits of the Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers.
• Assess state of compliance with appropriate regulations and lead or participate in the assessment of action plans to correct deficiencies.
• Implement risk assessments.
• Ensure completion, maintenance and sustainability of assigned training per specific roles to support the audit process.
• Provide leadership toward calling out site and multi-site compliance issues resulting from audit findings.
• Serve as subject matter expert on global regulated requirements and inspectional commitments.
• Provide support for domestic and international Regulatory Authority Inspections when necessary.
• Provide technical support/compliance review of multi-site/global documents resolving compliance issues.
• Interact with other functional leads to ensure Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.
• Alert senior and/or executive management of significant quality and compliance risks.
• Provide support for audit and inspection metrics as vital.
• Support Continual Improvement initiatives, programs and projects.

What We're Looking For

• Doctorate degree and 2 years of compliance experience
• Master’s degree and 4 years of compliance experience
• Bachelor’s degree and 6 years of compliance experience
• Associate’s degree and 10 years of compliance experience
• High school diploma / GED and 12 years of compliance experience

Nice to Have

• Lead Auditor Certification
• Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API), and Small Molecule
• Strong communication skills both verbal and written
• Domestic and International travel up to 50%

Benefits & Compensation

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.
• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Work Mode

This is a hybrid position open to locations in the U.S. (excluding Puerto Rico).

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.