A leading biotechnology company in Leinster is seeking a qualified professional to oversee quality management systems (QMS) in AI development. You will be responsible for ensuring compliance throughout the product lifecycle, developing Standard Operating Procedures (SOPs), and maintaining communication with partners. The ideal candidate will hold a degree in Engineering or Science, possess over 7 years of cGMP experience in medical devices, and have a thorough understanding of regulatory compliance standards. Join us to create an inclusive environment where diverse talents can thrive. #J-18808-Ljbffr
Job Summary: The Global Supply Chain and Strategy Director, Strategy & Performance acts as a vital connection between the various GSC&S functions, ensuring consistency and alignment across the organization's leadership that will ensure that we provide best in class services and continuity of supply to customers and patients while also ensuring we achieve our long-term aspirations of being the #1 rare disease company globally. This is what you will do: Strategic Planning and Execution: Collaborate with the GSC&S VP to develop and execute the strategic agenda for the Global Supply Chain & Strategy department. Drive the implementation of strategic initiatives and ensure alignment with corporate goals. AO Strategy Development: Support the GSC&S VP in defining AO’s direction by analyzing the internal & external environment, setting priorities, and choosing the actions needed to achieve long-term goals through frameworks, facilitation & road-mapping. Operational Insights: Support the VP of Global Supply Chain & Strategy by facilitating effective decision-making based on comprehensive operational and business insights. Alignment: Collaborate with cross-functional teams to ensure alignment and integration of supply chain activities with overall business objectives. Performance: Monitor and analyze supply chain performance metrics and develop action plans to address any issues or opportunities. Stakeholder Management: Develop and maintain strong relationships with key partners, and stakeholders. Change Management: Act as a change champion, to promote the benefits of change and motivate employees to embrace new ways of working. Lead by example and encourage others to adopt the desired behaviors. Program Management: Monitor and evaluate strategic project & program progress, engage stakeholders, and provide regular updates to senior leadership. Ensure programs are executed efficiently and contribute to the organization's success. Capabilities: Oversee the supply chain capabilities build, ensuring alignment with AZ 2030 objectives by enhancing key competencies and skills. Communication and Coordination: Serve as the primary point of contact for internal and external stakeholders. Facilitate effective communication and coordination within the function and across organizational functions. Annual Objective Planning: Lead the planning and development of the annual GSC&S objectives, ensuring that key milestones and initiatives are identified, prioritized, and aligned with the wider business objectives. Budget & Performance: Oversee budget planning and cost management. Ensure efficient resource allocation and supports GSC&S financial health and overall performance. External Visibility & Benchmarking: External stakeholder engagement including identifying partners to benchmark with and bring external learnings into GSC&S such as Gartner. Digital Partnership: Work closely with our IT Partner to ensure continuous alignment with digital roadmap and representing the supply chain for operations. Monthly GSC&S LT Meetings: Coordinate and facilitate monthly GSC&S LT meetings to ensure effective communication and decision-making among leadership team members. We would prefer for you to have: Bachelor's degree in business, operations management, or a related field. Advanced degree (MBA, etc.) preferred. Proven experience in a chief of staff or similar strategic support role, preferably within a global supply chain or operations environment. Strong understanding of strategic planning, project management, and lean methodologies. Excellent leadership, communication, and interpersonal skills. Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively. Date Posted 11-Mar-2026 Closing Date 25-Mar-2026 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
This is what you will do: The primary purpose of this position is to build internal QMS oversight for AI DHT or AI SaMD development with business partnering AI DHT / AI SaMD companies. The business partner (BP) shall develop the technologies and shall execute processes in line with their own QMS. The BP shall also complete the regulatory submissions for the product unless Alexion decides to perform this role. The DHT Q shall ensure key quality criteria are in place in the Alexion QMS so that development work can start and oversee the BP design control activity to ensure key quality milestones are achieved for EU and US markets. The DHT Q is the quality liaison between Diagnostics Strategy & Development group (Product Development), Medical Device Quality and Regulatory Affairs to ensure internal and partner compliance with Quality Standards, Regulations and D Design control activities for the clinical and commercial development of AI DHT/ AI SaMD products. The role enables efficient communication for decision making related to quality and product development. You will be responsible for: Responsible for creating QMS related SOPs and/or guidance documents for the collaboration with BP to meet requirements of ISO 13485:2016, IVDR, IEC 62304, FDA Part 820 QMSR. Clearly identify roles and responsibilities for Alexion and BPs for device technical documentation generation including DHF and Device Clinical Performance. Support R&D Quality in the supplier qualification process (Operational Due Diligence) during the onboarding of BP for clinical development. Responsible for ensuring that BP development process and regulatory strategy for such devices and systems comply with all WW regulatory requirements. Quality responsibilities for BP for which the DHT Q shall have oversight shall be documented in a BP quality oversight plan. Identification of any known or new gaps to SOPs. Support product development create Quality Plans or document mitigations to ensure gaps and risks are addressed appropriately ensuring project deliverables are compliantly kept on track. Liase with AstraZeneca partners to leverage existing resources, processes and procedures. Where appropriate involve AstraZeneca partners to support program deliverables. Device BPs shall supply Alexion with milestone development summary reports per the quality oversight plan. The DHT Q shall be responsible for Quality oversight, participation in the review and approval of key deliverables including Design Development, Regulatory submissions, Design Transfer activities including CAPA, Risk Management, Change control, Design Reviews. Responsible for providing input and review of Design Control deliverables e.g. per ISO 13485:2016 Section 7.3 Design and Development and IEC 62304. Assist in quality review of Regulatory submissions and response to queries. Supports regulatory inspections and compliance. Supports cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle. Other duties as assigned. You will need to have: B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry. Preferable 7 years +’ cGMP experience within quality in a medical device, SaMD R&D, ideally clinical phases through commercial. Understanding of Medical device development for the full lifecycle starting at the Design Control phases. Knowledge of the regulatory and compliance requirements of design control for AI DHT / AI SaMD medical devices (FDA QSR 21 CFR Part 820 / ISO 13485 and Regulation (EU) 2017/74 5). Demonstrated ability in decision making, problem solving and project management. Collaborate, negotiate, influence and lead in a matrix organization. Excellent communication and interpersonal skills. Proven record in demonstrating agility. We would prefer for you to have: Experience in successful development, filing and gaining approval for global regulatory submissions. Experience in development of AI DHT / AI SaMD and regulatory approval 510(K), De Novo or PMA. Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
A global biopharmaceutical company in Blanchardstown, Ireland, is seeking a Global Supply Chain and Strategy Director. In this role, you will be responsible for developing and executing the strategic agenda for the Global Supply Chain & Strategy department, monitoring performance metrics, and overseeing budget planning. The ideal candidate holds a bachelor's degree in business with substantial experience in a strategic support role within a supply chain environment. Excellent leadership and communication skills are essential for success in this position. #J-18808-Ljbffr
The NPI Planner (Senior Manager) is accountable for end-to-end supply planning for first commercial launches across all modalities, owning planning activities from 36 months pre-launch through 12 months post-launch , followed by a structured transition to the Supply Planning organisation. This is an exciting opportunity to be part of an organisation with strong growth ambitions and a robust pipeline , targeting the launch of multiple new products before 2030 . The role operates in a high-ambiguity environment, often managing multiple NPIs in parallel with staggered launch timings , and plays a critical role in reducing launch risk , ensuring the right inventory is in the right place at the right time, and enabling timely patient access to new therapies. The NPI Planner sits at the centre of launch decision-making, providing baseline assumptions, scenario-based insights, clear recommendations, and proactive risk escalation to senior leadership through Global S&OP forums. Accountabilities NPI Planning Ownership Own baseline supply planning for NPIs from 36 months prior to first commercial launch through 12 months post-launch Plan across all modalities (biologics, small molecules, devices, combination products) Develop, maintain, and actively challenge key planning assumptions and parameters, including: Demand uncertainty and ranges during the first 12–18 months post-launch Capacity readiness, constraints, and flexibility Lead times, yields, inventory policies, and launch buffers Define, manage, and track launch planning targets (service level, inventory positioning, and milestone adherence) Governance, Tools & Data Execute NPI planning using a structured Smartsheet NPI checklist , ensuring strong governance, documentation, and audit-ready traceability, while continuously updating and improving the checklist to embed lessons learned and evolving best practices. Ensure master data and planning alignment within OMP , including accurate NPI setup, parameters, and scenarios Actively support and contribute to the NPI Stage Gate process , ensuring planning readiness, assumptions, and risks are aligned to gate decisions and approvals Scenario & Range-Based Planning Lead range-based planning and scenario modelling within OMP Assess launch supply risks and trade-offs, including CDMO-related variability (capacity, lead times, yields, change readiness), Translate outputs into clear impacts, recommendations, and mitigations for review at Global S&OP Supply Reviews. Cross-Functional Leadership & Communication Act as the supply planning representative within the Global Operations Launch Team Partner closely with the NPI Project Senior Manager to align: Integrated launch timelines and critical milestones Planning assumptions and cross-functional dependencies Readiness criteria linked to NPI stage-gate decisions Prepare and deliver high-quality PowerPoint presentations for Global S&OP forums Confidently engage senior stakeholders, clearly communicating risks, trade-offs, and recommendations Proactively identify and escalate risks to launch readiness in line with evolving timelines and governance expectations Transition to Supply Planning Lead a structured handover of plans, assumptions, risks, and documentation to Supply Planning teams following 12 months post-launch Ensure continuity of planning ownership and stable supply performance post-transition. Essential Skills/Experience 8–10+ years ’ experience in supply planning, NPI, or launch planning within biopharma Demonstrated experience supporting first commercial product launches Experience working across complex, multi-modality supply chains Strong hands‑on experience with OMP (or a similar advanced planning system) Proven capability in scenario modelling, range-based planning, and executive-level communication High proficiency in Smartsheet, Power BI, Excel, and PowerPoint Structured, risk‑based thinker comfortable operating with incomplete data and evolving assumptions Desirable Skills/Experience APICS certification (CPIM and/or CSCP) or equivalent professional supply chain qualification Project management certification (e.g. PRINCE2 or equivalent) Experience with SAP ECC or SAP S/4HANA , with SAP S/4HANA preferred Experience working in organisations with mature IBP / S&OP governance Why AstraZeneca Here, your planning acumen directly accelerates access for some of the most underserved patients. You will work at the intersection of cutting‑edge science and high‑urgency launches, combining the energy of a nimble biotech with the reach and rigor of a global biopharma. We bring unexpected teams into the same room to unleash bold thinking, act with urgency, and turn insight into action. You will be surrounded by people who value kindness alongside ambition, who invest in your growth, and who expect your voice at the table as we reimagine how quickly and reliably new therapies can reach those who need them most. Call to Action If you are ready to turn uncertainty into launch certainty and build the supply backbone for life‑changing medicines, we want to hear how you will make it happen! Date Posted 03-Mar-2026 Closing Date 02-Mar-2026 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
