Sr. Mgr External Quality

Career Category

Quality

Job Description

• 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.

• Serve as the main Quality point of contact for deviations, change controls,, CAPAs author and revision of quality agreements 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.

• When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and Amgen staff members.

• Meet with Quality, Production, Regulatory, and Logistics personnel at the CMO sites as necessary or during regularly scheduled meetings for issues relating to Amgen products.

• Represent Quality and quality activities from the CMO site on Amgen project teams.

• Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement

• Ensure that the CMO Site has an appropriate Data Integrity program and if needed conduct DI assessment at that site.

• Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as presenter as applicable or required.

• Manage inspection readiness of the CMO & prepare Inspection playbooks to ensure success

  •Represent Amgen as Person-In-Plant as applicable or required

• Identify and mitigate Risk at the CMO or testing Laboratories.

• Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer

• Escalate risks or roadblocks to management

• Identify prioritization opportunities and determine when escalation is necessary

• Strong partnership/relationship with CMO / testing Lab

• Preferred Skills & Experience

• 10 + years' biotech or pharmaceutical industry experience

  Additional European Languages - desirable not essential

• Significant Quality experience at Aseptic Manufacturing facilities

• QP eligibility desirable

• 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

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