Amgen Sr. Mgr External Quality in Dun-Laoghaire-Rathdown, Ireland

  • 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 AgreementEnsure 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 successRepresent 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 managementIdentify prioritization opportunities and determine when escalation is necessary*Strong partnership/relationship with CMO / testing Lab

  • Additional Job Description 10 + years biotech or pharmaceutical industry experienceAdditional European Languages - desirable not essentialSignificant Quality experience at Aseptic Manufacturing facilitiesAble 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