Senior Manager Quality Technical Services (External Supply Quality)

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p><b>Senior Manager Quality Technical Services (External Supply Quality)</b></p><p></p><p><b>Job Summary</b></p><p></p><p>The Senior Manager, Quality Technical Services (QTS) is a key role within External Supply Quality (ESQ), responsible for driving execution excellence across Amgen’s external manufacturing network through a proactive, risk-based oversight model.</p><p></p><p>This role provides advanced technical and compliance expertise to ensure reliable quality supply across contract manufacturing organizations (CMOs) and contract test labs (CTLs) while supporting exponential business growth.</p><p></p><p>The Senior Manager serve as a strategic partner to site-facing ESQ Site Leads and External Supply (ES) teams, providing expert guidance on significant deviations, regulatory escalations, inspection readiness, risk governance, and post-release event management.</p><p></p><p>This position operates in a highly dynamic, matrixed, global environment and requires strong collaboration across Quality, Manufacturing, Regulatory, Process Development, Supply Chain, and CMO/CTL partners.</p><p></p><p><b>Primary responsibilities</b></p><ul><li>Drive implementation of a risk-based oversight framework for CMOs/CTLs to ensure reliable quality supply</li><li> 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.</li><li>Provide expert guidance on significant deviations, complex investigations, and regulatory escalations.</li><li>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.</li><li>Lead ESQ-hosted audits and regulatory inspections, including inspection readiness, logistics coordination, response management, and CAPA follow-up.</li><li>Represent ESQ on cross-functional teams supporting NPI, tech transfer, PPQ, and lifecycle management activities</li><li>Monitor site performance through quality metrics and intelligence signals; identify trends and drive proactive mitigation actions.</li><li>Escalate significant risks or compliance concerns to senior leadership as appropriate.</li><li>Drive continuous improvement initiatives to align external network practices with internal best standards.</li><li>Build and maintain strong partnerships with CMO and CTL quality leadership to enhance alignment/standardization, accountability and performance</li></ul><p></p><p><b>Competencies/Skills:</b></p><p></p><ul><li>Ability to travel (~20%) to sites in our CDMO/CTL network and ability to work successfully in a highly international environment</li><li>Extensive experience in cGMP quality oversight within external manufacturing or CMO environments.</li><li>Strong background in deviation management, advanced root cause analysis, and CAPA effectiveness.</li><li>Significant experience supporting regulatory inspections and health authority interactions.</li><li>Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop options and present solutions to technical problems of moderate complexity</li><li>Experience in aseptic manufacturing environments preferred</li><li>Demonstrated ability to work independently and deliver right first-time results under minimal direction.</li><li>Escalate issues professionally and in a timely manner.</li><li>Demonstrated ability to influence senior stakeholders and operate effectively in a matrixed global organization</li><li>Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills.</li><li>Data driven Decision Making skills and confidence to challenge others on decisions.</li><li>Teamwork and ability to coach, mentor and/or cross train colleagues within core technical areas.</li><li>Ensures compliance within regulatory environment (EU GMP compliance, FDA CFR)</li><li>Location based in Ireland.</li></ul><div></div><p><b>Basic Qualifications</b></p><p>Doctorate degree<br />OR<br />Master’s degree and 4 years of Quality or Manufacturing experience<br />OR<br />Bachelor’s degree and 6 years of Quality or Manufacturing experience<br />OR<br />Associate’s degree and 10 years of Quality or Manufacturing experience<br />OR<br />High school diploma / GED and 12 years of Quality or Manufacturing experience</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.