Senior Manager, Quality
Description Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE.
Alignment with CTA / Marketing Application.
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.
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.
QP Certification in compliance with marketing authorisations, of products manufactured at Amgen CMOs.
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.
Authority Decision to release or Reject batchesDecision to approve or reject deviations, Change Control, CAPADecision to approve QAGRProvide Quality position on GMP related topics and strategy for the siteDecision to approve Master batch Records/Raw Material SpecificationsDecision to QP certify batchesBasic Qualifications:
Doctorate degree & 2 years of directly related experience OR
Master's degree & 4 years of directly related experience OR
Bachelor's degree & 6 years of directly related experience OR
Associate's degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
10 + years biotech or pharmaceutical industry experience.
Qualified Person status is essentialAdditional European Languages - desirable not essentialSignificant Quality experience at Aseptic Manufacturing facilitiesAble to facilitate and influence senior stakeholders and partnersAble to successfully manage workload and timelinesFamiliarity with basic project management toolsAbility to negotiate a strategic position after taking feedback from multiple sourcesStrong project management, problem-solving, and analytical skillsDemonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality resultsCollaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolutionAbility to operate in a matrixed or team environment with site, functional, and executive leadershipExperience driving decision making by using DAI principlesExperience with the "variation management" process
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