Description
+ **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 experienceAdditional European Languages – desirable not essential
+ Significant Quality experience at Aseptic Manufacturing facilities
+ QP eligibility desirable
+ 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
