Amgen Specialist External Quality in Dublin, 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.

  • Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.

  • Review completed production batch records as necessary and other cGMP documents from CMOs.

  • 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.) 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 applicable or required.

  • Identify and mitigate Risk at CMO.

  • Monitor and communicate site performances in means of quality metrics to Amgen and CMO

  • Escalate risks or roadblocks to QA site lead / Mangement

  • Identify prioritization opportunities and determine when escalation is necessary

  • Strong partnership/relationship with CMO Authority

  • Decision to release or reject batches

  • Decision to approve or reject a CMO change implementation / deviation Outputs

  • Dispositioned batches to ensure supply

  • Review Assessed and Approved applicable Quality Records

  • Deliver various documents/ information's to RA for launce or filing activity

  • APR / Metrics / MR outputs

  • Qualifications The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

  • Preferred Requirements

  • 5 + years' biotech or pharmaceutical industry experience

  • 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 Competencies

  • Ability to influence other in a matrix environment

  • Ability to drive continuous improvements

  • Project Management

  • Leading / managing cross-functional teams

  • Problem Solving

  • Detail Oriented

  • Critical Thinking skills

  • Creative / Innovative thinking

  • Operational excellence mind-set

  • Managing diverse relationships

  • Ability to make complex decisions

  • Ability to speak with conviction

  • Ability to present

  • Ability to manage and implement change

  • Business acumen

  • Interpreting GMP regulations