Quality Compliance, Senior Manager

Role Summary

Quality Compliance, Senior Manager — Drive Global Quality Compliance Audits and related tasks to achieve corporate and departmental goals within Amgen's Quality Compliance framework.

Responsibilities

• Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.
• Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.
• Implements risk assessments.
• Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process.
• Has documented experience and working knowledge of Amgen’s competencies including but not limited to manufacturers or intermediates, API/drug substance, drug product, combination products, medical devices, and laboratories.
• Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings.
• Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable.
• Provides support for domestic and international Regulatory Authority Inspections when necessary.
• Provides technical support/compliance review of multi-site/global documents resolving compliance issues, if/when necessary.
• Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.
• Alerts senior and/or executive management of significant quality, and compliance risks.
• Provides support for audit and inspection metrics as vital.
• Supports Continual Improvement initiatives, programs and projects.

Qualifications

• Basic Qualifications:
  • Doctorate degree and 2 years of compliance experience OR
  • Master’s degree and 4 years of compliance experience OR
  • Bachelor’s degree and 6 years of compliance experience OR
  • Associate’s degree and 10 years of compliance experience OR
  • High school diploma / GED and 12 years of compliance experience
• Preferred Qualifications:
  • Lead Auditor Certification
  • Audit Experience in DS/DP/FDP, Medical Device, Combination Product, API, and/or Small Molecule
  • Strong communication skills both verbal and written
  • Domestic and International travel up to 50%

Skills

• Quality compliance expertise
• Audit planning and execution
• Regulatory knowledge (global)
• Risk assessment and corrective action planning
• Communication and stakeholder management

Education

• As outlined in Basic Qualifications (degree-based requirements)

Additional Requirements

• Domestic and International travel up to 50% (Preferred)
• U.S. work authorization