Supply Chain Manager - Compliance

Live

What you will do

Let’s do this. Let’s change the world.

Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

The Supply Chain Specialist will hold primary responsibility for comprehensive management of ADL Supply Chain processes, encompassing Change Controls, Standard Operating Procedures (SOPs), oversight of departmental quality metrics, and resolution of supply chain deviations. The role demands a proactive approach to process governance and continuous improvement to uphold compliance and operational excellence.

Supporting the day-to-day operation of complex automation systems at Amgen Dun Laoghaire (ADL) which is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.

Key Responsibilities:

• Provide end to end project management of Supply Chain Change Controls (e.g. Supply Chain, External Warehouse, and Internal Warehouse changes) including generation of project timelines, critical milestones, identifying required resources from support functions, determination of critical path & appropriate sequence of task completion.
• Own, manage and resolve SC Major Deviations and some SC Minor Deviations, leading investigation teams in order to determine root cause, product impact potential, and Corrective & Preventative Actions (CAPA), and CAPA EVs.
• Providing support and technical mentorship to others in SC who own and manage Minor Deviations, CAPAs, CAPA EVs. Working closely with all SC sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Short-Term Planning, Product Planning, and, Strategic Planning), Quality, Manufacturing, Inspection and Packaging.
• Writing Quality Risk Assessment Reports, and managing review and approval cycles with key stakeholders.
• Develop, review and update Supply Chain Standard Operating Procedures (SOPs) working with the relevant owners and SMEs.
• Develop protocols for execution in Supply Chain in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
• Provide technical (Root Cause Analysis) RCA guidance to colleagues on EHS, quality and business processes.
• Trend analysis of quality system events relating to Supply Chain maintaining oversight of department milestones (CAPA’s, CAPA EVs, change controls and deviations).
• Assisting as needed in audits by external agencies in answering questions related to deviations and change controls.
• Engagement with global network Supply Chain leads along with local ADL resources as required.
• Assuring appropriate escalation to various levels of management if timeline requirements for deviation processing are exceeded.
• Performing other duties as the need arises by SC Management.

Win

What we expect of you

The successful candidate for this role will bring the following education, skills and experience

• Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain) or
• Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain).
• Experience with investigations into quality deviations and determination of product impact potential, root cause, and corrective actions.
• Experience in running multiple, competing priorities in a fast-paced environment with Project Management experience.
• Strong technical writing and presentation skills.
• Ability to be flexible and manage change.
• Ability to communicate and collaborate with technical and management staff.
• Experience interacting with representatives of regulatory agencies.
• 6-Sigma / Lean Yellow Belt certification (Preferred).
• Proficient in viewing of SAP ERP (Preferred).

Thrive

What you can expect of us

In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.