Senior Manager Quality Technical Services

• Drive implementation of a risk-based oversight framework for CMOs/CTLs to ensure reliable quality supply
• Maintain a cross-platform compliance risk register
• ensure appropriate risk mitigation, governance visibility, and escalation
• Align with due diligence and onboarding teams to embed risk framework early project lifecycle
• Provide expert guidance on significant deviations, complex investigations, and regulatory escalations
• Oversee post-release issue management and ensure compliance with Amgen reporting requirements
• Partner with manufacturing sites, Corporate Quality, and Regulatory Affairs to coordinate regulatory reporting and health authority communications
• Lead ESQ-hosted audits and regulatory inspections, including inspection readiness, logistics coordination, response management, and CAPA follow-up
• Represent ESQ on cross-functional teams supporting NPI, tech transfer, PPQ, and lifecycle management activities
• Monitor site performance through quality metrics and intelligence signals
• identify trends and drive proactive mitigation actions
• Escalate significant risks or compliance concerns to senior leadership as appropriate
• Drive continuous improvement initiatives to align external network practices with internal best standards
• Build and maintain strong partnerships with CMO and CTL quality leadership to enhance alignment/standardization, accountability and performance

• Doctorate degree
• OR Master’s degree and 4 years of Quality or Manufacturing experience
• OR Bachelor’s degree and 6 years of Quality or Manufacturing experience
• OR Associate’s degree and 10 years of Quality or Manufacturing experience
• OR High school diploma / GED and 12 years of Quality or Manufacturing experience
• Extensive experience in cGMP quality oversight within external manufacturing or CMO environments
• Strong background in deviation management, advanced root cause analysis, and CAPA effectiveness
• Significant experience supporting regulatory inspections and health authority interactions
• Experience in aseptic manufacturing environments preferred
• Demonstrated ability to work independently and deliver right first-time results under minimal direction
• Demonstrated ability to influence senior stakeholders and operate effectively in a matrixed global organization
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation and good Presentation skills
• Data driven Decision Making skills and confidence to challenge others on decisions
• Teamwork and ability to coach, mentor and/or cross train colleagues within core technical areas
• Ensures compliance within regulatory environment (EU GMP compliance, FDA CFR)
• Ability to travel (~20%) to sites in our CDMO/CTL network and ability to work successfully in a highly international environment

Experience in aseptic manufacturing environments