Sr. Mgr External Quality

Amgen; Dublin; On-site; EUR 120,000 - 160,000; Full time

Job summary

Amgen Dun Laoghaire – Dublin is seeking a Senior Manager External Supply to lead quality activities across contract manufacturing partners. The role ensures manufacturing, testing and release of Amgen products at CMOs, with primary responsibility for deviations, change controls, CAPAs and batch disposition.

The position requires extensive experience in biotech/pharma quality, aseptic manufacturing, and the ability to influence senior stakeholders.

Qualifications

• 10+ years of biotech/pharmaceutical industry experience required.
• Significant quality experience in aseptic manufacturing facilities.
• Additional European languages desirable but not essential.

Responsibilities

• Be an integral quality member of the cross-functional contract manufacturing team.
• Serve as the main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contractual quality obligations and regulatory requirements.
• Review production batch records and approve master batch records and other cGMP documents.
• Provide quality oversight of manufacturing, testing, and release of Amgen products at CMOs.
• Facilitate communication on deviations, change controls, complaints and batch disposition between CMO and Amgen staff.
• Attend meetings with Quality, Production, Regulatory, and Logistics at CMO sites as needed.
• Represent Quality activities from the CMO site on Amgen project teams.
• Support DI programs, tech transfer, PPQ filings, and related activities at the site.
• Ensure data integrity programs are in place and conduct DI assessments when needed.
• Represent Amgen at regulatory inspections and Notified Body audits as required.
• Prepare inspection playbooks and assist with inspection readiness at CMO sites.
• Identify and mitigate risks at CMOs or testing labs.
• Monitor quality metrics and escalate risks or roadblocks where necessary.
• Collaborate with CMOs and testing labs to drive timely issue resolution.

Skills

Quality management

Cross-functional teamwork

Project management

European languages

Job description

Senior Manager External Supply

Specified Purpose Contract (12 Months)

Amgen Dun Laoghaire – Dublin

Responsibilities

• 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

Preferred Skills & Experience

• 10 + years’ biotech or pharmaceutical industry experience
• Additional European Languages – desirable not essential
• Significant Quality experience at Aseptic Manufacturing facilities

QP Eligibility & Additional Requirements

QP eligibility desirableAble to facilitate and influence senior stakeholders and partnersAble to successfully manage workload and timelinesFamiliarity with basic project management toolsAbility to negotiate a strategic position after taking feedback from multiple sourcesStrong project management, problem-solving, and analytical skillsDemonstrated ability to lead cross-functional teams, consistently deliver on‑time, and high‑quality resultsCollaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolutionAbility to operate in a matrixed or team environment with site, functional, and executive leadershipExperience driving decision making by using DAI principlesExperience with the “variation management” process