Senior Manager Corporate Quality Compliance

Career Category

Quality

About Amgen

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech, focusing on Oncology, Inflammation, General Medicine, and Rare Disease.

Global Quality Compliance, Senior Manager – What you will do

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals, including:

• Coordinates and leads or participates 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 all applicable regulations and identify top compliance risks.
• Ensures completion, maintenance, and sustainability of assigned training per role to support the audit process (including understanding how to apply regulatory requirements, changes to regulations, guidelines, standards, trends and expectations).
• Supports preparation of the annual audit plans, as assigned.
• Assesses state of compliance with appropriate regulations and participates in 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.
• Provides support for domestic and international Regulatory Authority Inspections when necessary.
• Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, special task forces).
• Interacts with other functional area leads to ensure 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%

What we expect of you

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, a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

Preferred Qualifications

• Auditing experience in internal audit, affiliate, CMO, contract laboratory, transportation/logistics/distribution/warehouse services
• 50% international travel requirement
• Knowledge of international regulations and standards
• Auditing certification preferred
• Detail oriented
• Organizational and multi-task skills

What you can expect of us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $138,264.40 – $187,063.60 USD. Actual salary will vary based on relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan, based on eligibility, which may include:

• 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
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Application deadline

Amgen does not have an application deadline for this position; applications will be accepted until a sufficient number are received or a candidate is selected.

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. Individuals with disabilities will be provided reasonable accommodation upon request.