Job Description
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 partners Serve 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 agreements Lead 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 areas Review / Approve Master Batch Records Prepare inspection playbooks Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management Perform Person in Plant activities as required APR Data Provider Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer Identify prioritization opportunities and determine when escalation is necessary Develop strong partnership/relationship with CMO / testing Lab Manage submission related activities at CMOs as it pertains to international launches, global expansion etc. Authority Decision to release or Reject batches Decision to approve or reject deviations, Change Control, CAPA Decision to approve QAGR Provide Quality position on GMP related topics and strategy for the site Decision to approve Master batch Records/Raw Material Specifications Decision to QP certify batches Basic 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: Preferred Requirements: 10 + years biotech or pharmaceutical industry experience. Qualified Person status is essential Additional European Languages - desirable not essential Significant Quality experience at Aseptic Manufacturing facilities 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 Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.