Senior Manager Quality Technical Services (External Supply Quality)

Senior Manager Quality Technical Services (External Supply Quality)

Job Summary

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.

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.

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.

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.

Primary responsibilities

• 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

Competencies/Skills:

• Ability to travel (~20%) to sites in our CDMO/CTL network and ability to work successfully in a highly international environment
• 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.
• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop options and present solutions to technical problems of moderate complexity
• Experience in aseptic manufacturing environments preferred
• Demonstrated ability to work independently and deliver right first-time results under minimal direction.
• Escalate issues professionally and in a timely manner.
• 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 (eg investigations, procedures, change controls) 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)
• Location based in Ireland.

Basic Qualifications

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