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Amgen Logo Amgen · Quality Control

Sr. Mgr External Quality

Ireland, Dun Laoghaire · Job Posted May 16, 2026
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Job Description

Sr. Mgr External Quality - Ireland - Dun Laoghaire. Work Location Type: Flex Commuter / Hybrid. Category: Quality.

Job Responsibility

  • Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain etc.
  • Serve as the main Quality point of contact for deviations, change controls,, CAPAs author and revision of quality agreements and batch disposition etc. related to Amgen product
  • Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs
  • When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and Amgen staff members
  • Meet with Quality, Production, Regulatory, and Logistics personnel at the CMO sites as necessary or during regularly scheduled meetings for issues relating to Amgen products
  • Represent Quality and quality activities from the CMO site on Amgen project teams
  • Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
  • Ensure that the CMO Site has an appropriate Data Integrity program and if needed conduct DI assessment at that site
  • Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as presenter as applicable or required
  • Manage inspection readiness of the CMO & prepare Inspection playbooks to ensure success
  • Represent Amgen as Person-In-Plant as applicable or required
  • Identify and mitigate Risk at the CMO or testing Laboratories
  • Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer
  • Escalate risks or roadblocks to management
  • Identify prioritization opportunities and determine when escalation is necessary
  • Strong partnership/relationship with CMO / testing Lab

Requirements

  • 10 + years' biotech or pharmaceutical industry experience
  • Significant Quality experience at Aseptic Manufacturing facilities
  • QP eligibility desirable
  • Able to facilitate and influence senior stakeholders and partners
  • Able to successfully manage workload and timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Strong project management, problem-solving, and analytical skills
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
  • Experience with the “variation management” process

Nice to have

  • Additional European Languages - desirable not essential
  • QP eligibility desirable
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