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QA Sr. Manager

3 months ago

Dublin, Ireland Amgen Full time

Key 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

  • 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

  • Significant Quality experience at Synthetics Manufacturing facilities

  • 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