Senior Manager Corporate Quality Compliance

Regulatory Jobs; United States; Hybrid; USD 138.000 - 187.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Remote and hybrid work arrangements

Zusammenfassung

Amgen seeks a Senior Manager, Global Quality Compliance to lead audits and regulatory readiness across sites, affiliates and suppliers. You will drive QA approvals, training programs, and compliance metrics, while guiding cross-functional teams and informing executives of risks.

Travel approx. 50% domestically and internationally; requires advanced degrees and a CQ auditor background. The role offers a total rewards plan and flexible work arrangements.

Qualifikationen

• Doctorate or higher with significant auditing experience.
• Master's/ Bachelor's with auditor experience and relevant certifications considered.
• Experience with global regulatory inspections and quality systems.

Aufgaben

• Execute Global Quality Compliance tasks and projects to meet corporate goals.
• Coordinate and lead audits of the Corporate Quality Management System and sites/affiliates.
• Maintain training per role to support audit processes and regulatory requirements.
• Support annual audit plans and assess compliance actions.
• Provide leadership to resolve site and multi-site compliance issues and alert management to risks.
• Serve as SME on global regulatory requirements and inspections.

Kenntnisse

Aseptic Processing

Drug Product

Drug Substance

Combination Products

Data Integrity

Auditing

Leadership

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

Quality Management System (QMS)

Jobbeschreibung

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.
• Assess 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.