Senior Specialist, Quality Assurance

Role Summary

Senior Specialist, Quality Assurance responsible for leading quality activities within Global Supplier Quality (GSQ) and Supplier Quality Management (SQM), with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. You will drive quality excellence across Amgen’s external network and contribute to successful regulatory outcomes.

Responsibilities

• Own and lead the SQM/GSQ inspection readiness processes, ensuring best-in-class inspection execution and outcomes across global and virtual sites.
• Provide strategic and tactical leadership for inspection and audit preparation, inspection and audit room execution (front room/back room), fielding questions, managing change, and guiding teams through inspection and audit activities.
• Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites, partnering closely with established site leads and subject matter experts.
• Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates to ensure strong audit/inspection preparedness and alignment to regulatory expectations and industry trends.
• Maintain and continuously improve inspection readiness processes, including strategy sessions, pressure tests, and readiness tools; represent GSQ in audits, inspections, and global networks.
• Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and Amgen Global Quality Compliance internal audits.
• Drive proactive identification, communication, and resolution of site and cross-functional compliance risks across the global network.
• Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation, testing, training, and post-implementation support for >300 staff.
• Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation. (e.g., DQMS for A&I in 2026).

Skills

• Risk-based decision making
• Cross-functional collaboration & leadership
• Technical writing
• Problem solving
• Continuous improvement
• Project / Program management

Qualifications

• Required: Doctorate degree and 2 years of Quality Compliance experience; OR Master’s degree and 4 years of Quality Compliance experience; OR Bachelor’s degree and 6 years of Quality Compliance experience; OR Associate’s degree and 10 years of Quality Compliance experience; OR High school diploma / GED and 12 years of Quality Compliance experience
• Preferred: Bachelor’s degree in Life Sciences or Engineering
• Preferred: Experience leading or participating in key roles for Regulatory/Health Authority inspections, including preparation, execution, and response phases
• Preferred: Experience auditing and defending processes/procedures during inspections
• Preferred: 7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
• Preferred: Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management
• Preferred: Strong understanding of EU and US cGMP, exposure to GDPs, and knowledge of supplier/partner quality challenges
• Preferred: Demonstrated ability to work autonomously, communicate effectively, present data clearly, and navigate ambiguity with structured problem-solving
• Preferred: Experience leading cross-functional teams and driving continuous improvement initiatives
• Preferred: Ability to maintain strong remote working relationships across global teams

Additional Requirements

• Ability to travel regionally and internationally as needed