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
10 + years' biotech or pharmaceutical industry experience
Additional European Languages - desirable not essential
Significant Quality experience at Aseptic Manufacturing facilities
QP eligibility desirable
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