Amgen Specialist External Quality in Dublin, Ireland
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.
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
Leading / managing cross-functional teams
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
Interpreting GMP regulations