External Supply QA Senior Manager

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Description

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations.   You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.

• →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.
• →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.

• 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