Sr. Mgr External Quality

Amgen; Ireland; On-site; EUR 110,000 - 150,000; Full time

Job summary

Amgen Dun Laoghaire in Dublin is seeking an experienced Senior Manager External Supply to lead quality oversight of CMOs, manage deviations, CAPAs and batch disposition, and ensure compliance with quality agreements. You will coordinate with Quality, Production, Regulatory and Logistics at CMOs, prepare inspection playbooks, and represent Amgen in product-specific regulatory inspections.

This role requires 10+ years biotech/pharma experience, strong leadership, and ability to influence senior

Qualifications

• Senior Manager with 10+ years in biotech/pharma
• Experience managing CMOs and quality agreements
• Experience with regulatory inspections and Notified Body audits
• Ability to lead cross-functional teams and manage timelines
• Strong quality systems knowledge including DI, CAPA, deviations

Responsibilities

• Be an integral quality member of cross-functional contract manufacturing team
• Serve as main Quality point of contact for deviations, change controls, CAPAs
• Manage CMOs to contractual quality obligations
• Review batch records and approve master batch records
• Provide quality oversight of manufacturing, testing, release at CMOs
• Facilitate communication between CMO and Amgen staff on deviations and batch disposition
• Represent Quality at CMO sites in project teams
• Prepare inspection playbooks and ensure inspection readiness
• Represent Amgen as Person-In-Plant as needed
• Data integrity program assessment at sites
• Support regulatory inspections and Notified Body audits

Skills

Quality leadership

CMO management

Deviations handling

Change controls

CAPA authoring

Batch disposition

Data Integrity

Regulatory inspections

Cross-functional collaboration

Job description

• 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

• Senior Manager External Supply
• Specified Purpose Contract (12 Months)
• Amgen Dun Laoghaire - Dublin
• 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