Senior Manager, Corporate Quality Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for executing assigned tasks and projects within Global Quality Compliance to meet corporate and departmental objectives.

• Coordinates, leads, or participates in Global Quality Compliance Audits for the Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers.

• Ensures the completion, maintenance, and sustainability of training assignments specific to roles in support of the audit process.

• Aids in the preparation of annual audit plans as designated.

• Evaluates compliance status with relevant regulations and participates in assessing action plans to rectify deficiencies.

• Offers technical and organizational leadership to resolve compliance issues at single and multiple sites.

• Notifies executive management about significant quality and compliance risks.

• Acts as a subject matter expert on global regulatory requirements and inspection commitments.

• Provides assistance during domestic and international Regulatory Authority Inspections when required.

• Functions as a senior Global Quality Compliance representative on cross-functional teams and collaborates with other departments to accomplish objectives.

• Engages with leads from other functional areas to ensure alignment of Amgen Standards, strategies, and directives with current regulations and regulatory expectations.

• Supplies support for audit and inspection metrics as needed.

• Assists in Continual Improvement initiatives, programs, and projects.

⛳️ Requirements

• Doctorate degree with 2 years of auditor experience OR Master’s degree with 6 years of auditor experience OR Bachelor’s degree with 8 years of auditor experience OR Associate’s degree with 10 years of auditor experience OR High school diploma/GED with 12 years of auditor experience.

• At least 2 years of experience in directly managing personnel and/or leadership experience guiding teams, projects, programs, or directing resource allocation.

• Experience in Aseptic Processing, Drug Product, Drug Substance, Combination Products, and Data Integrity.

• Auditing experience in internal audits, affiliates, CMO, Contract laboratories, Transportation/Logistics/Distribution/warehouse services.

• Familiarity with international regulations and standards.

• Auditing certification is preferred.

• Strong attention to detail.

• Excellent organizational and multi-tasking skills.

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• 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 feasible.