Senior QA Lead, External Supply & CMOs

Amgen; Ireland; Remote; EUR 91,000 - 123,000; Full time

Job summary

Amgen is seeking a Quality professional to join our global quality teams, collaborating with contract manufacturing sites to ensure a reliable supply of high‑quality products to patients. The role emphasizes deviations, CAPAs, batch disposition, and regulatory readiness across CMOs.

You will review master batch records, provide QA oversight of manufacturing and release, and support regulatory inspections. Strong cGMP knowledge and cross‑functional collaboration are essential.

Qualifications

• Doctorate or Master’s/Bachelor’s depending on years of directly related experience.
• Academic qualifications as listed under Basic Qualifications.
• Experience in biotech/pharma environments is advantageous.
• Strong understanding of quality systems and cGMP.
• Ability to work across cross-functional teams and CMOs.

Responsibilities

• Be an integral quality member of 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 elevate 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

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen is seeking a Quality professional to join our global quality teams, collaborating with contract manufacturing sites to ensure a reliable supply of high‑quality products to patients. The role emphasizes deviations, CAPAs, batch disposition, and regulatory readiness across CMOs.

You will review master batch records, provide QA oversight of manufacturing and release, and support regulatory inspections. Strong cGMP knowledge and cross‑functional collaboration are essential.