Sr. Mgr External Quality

Biopharma Careers; Dublin; On-site; EUR 91,000 - 123,000; Full time

Job summary

Amgen Dun Laoghaire - Dublin seeks a Senior Manager External Supply to lead quality activities in contract manufacturing for Amgen products. You will act as main quality contact for deviations, change controls, CAPAs, and batch dispositions, and manage CMOs to meet quality agreements and regulatory requirements.

Role requires extensive experience in biotech/pharma quality, ability to lead cross-functional teams, and ensure product release readiness across CMOs.

Qualifications

• 10+ years biotech/pharmaceutical quality experience.
• Significant QA experience at aseptic manufacturing facilities.
• Able to influence senior stakeholders and drive alignment with partners.

Responsibilities

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Serve as main Quality point of contact for deviations, change controls, CAPAs and batch disposition.
• Manage CMOs to contractual obligations related to Quality Agreement, specifications, quality, safety and regulatory requirements.
• Review production batch Records and approve Master Batch Records and other cGMP documents from CMOs/Contract Labs.
• Provide quality oversight of manufacturing, testing and release of Amgen products at CMOs.
• Facilitate communication on deviations, change controls, complaints and batch disposition between CMO and Amgen staff.
• Engage with Quality, Production, Regulatory and Logistics teams at CMO sites during scheduled meetings.

Skills

Quality leadership

Cross-functional

cGMP knowledge

Deviation & CAPA

CMO management

Regulatory readiness

QP eligibility

Project management

Job description

Career Category

Quality

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

Salary Range

91,082.60EUR-123,229.40EUR