Career CategoryQualityJob DescriptionDescriptionQuality and Compliance Oversight CMOs and alignment with CTA / Marketing Application.Key ResponsibilitiesBe 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.Lead the representation, communication and management of quality issues with internal partners and external partnersServe as the main Quality point of contact and approver for deviations, change controls, CAPAs, 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.QA review of all documentation associated with batch release to ensure GMP compliance.Negotiator, author and Approver of quality agreementsLead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as applicable or required.Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers as required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areasReview / Approve Master Batch RecordsPrepare inspection playbooksIdentify and mitigate Risk at the CMO or testing Laboratories and/or escalate to managementPerform Person in Plant activities as requiredAPR Data ProviderProvide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality AgreementMonitor and communicate site performances in means of quality metrics to Amgen and Contract ManufacturerIdentify prioritization opportunities and determine when escalation is necessaryDevelop strong partnership/relationship with CMO / testing LabManage submission related activities at CMOs as it pertains to international launches, global expansion etc.AuthorityDecision to release or reject batchesDecision to approve or reject an External site change implementation / deviationAdvise on External site statusAdvise on External site Inspection readinessIdentify opportunities and issues, then determine when escalation is necessaryBasic Qualifications:Doctorate degree ORMaster’s degree & 2 years of directly related experience ORBachelor’s degree & 4 years of directly related experience ORAssociate’s degree & 10 years of directly related experience ORHigh school diploma / GED & 12 years of directly related experiencePreferred Qualifications:4+ years of quality and manufacturing experience in biotech or pharmaceutical industryBachelor’s Degree in a Science FieldcGMP ExperienceAbility to oversee multiple projects simultaneouslyAble to successfully manage workload to timelinesFamiliarity with basic project management toolsAbility to negotiate a position after taking feedback from multiple sourcesDemonstrated ability to consistently deliver on-time, and high-quality resultsAbility to operate in a matrixed or team environmentAbility to manage diverse relationshipsAbility to lead and manage cross-functional teamsUnderstanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)Ability to travel +/- 20% of time to domestic and international Amgen/External sites.