Sr. Mgr External Quality

Amgen SA; Dún Laoghaire; On-site; EUR 110,000 - 140,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Manager External Supply to lead quality oversight of contract manufacturing for Amgen products. The role focuses on deviations, CAPAs, batch disposition, and regulatory interactions across CMOs, ensuring cGMP compliance.

The successful candidate will manage quality programs, lead cross-functional teams, and drive risk management and data integrity initiatives at the CMO sites, contributing to successful inspections and product release.

Qualifications

• 10+ years' biotech or pharmaceutical industry experience.
• Experience with aseptic manufacturing facilities and cGMP.
• QP eligibility desirable.
• Ability to influence senior stakeholders and manage timelines.
• Strong project management, problem-solving, and analytical skills.
• Experience with quality systems and regulatory inspections.
• Familiarity with variation management processes.

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing teams.
• Serve as main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Manage CMOs to contractual obligations related to quality, safety, and regulatory requirements.
• Review production batch records and approve master batch records and other cGMP documents.
• Provide quality oversight of manufacturing, testing, and release at CMOs.
• Facilitate communication on deviations, change controls, complaints, and batch disposition with CMOs and Amgen staff.
• Meet with Quality, Production, Regulatory, and Logistics at CMO sites as needed.
• Represent Quality activities from CMO site on Amgen project teams.
• Support CMO site activities (NPI, tech transfer, PPQ, filings) per Quality Agreement.
• Ensure CMO Site has Data Integrity program and conduct DI assessments if needed.
• Represent Amgen at Regulatory inspections and Notified Body audits as presenter if required.
• Manage inspection readiness and prepare inspection playbooks.
• Represent Amgen as Person-In-Plant as applicable.
• Identify and mitigate risk at CMO or testing labs.
• Monitor and communicate site performance via quality metrics; escalate risks.
• Develop prioritization and escalation as needed; maintain strong CMO relationships.
• Collaborate across site, functional, and executive leadership.

Skills

Quality management

Project management

Stakeholder influence

Cross-functional leadership

Data Integrity

Regulatory knowledge

Risk management

Quality systems

Communication

Quality Assurance

Audit readiness

CAPA handling

Job description

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