Warehouse Support, Senior Specialist (24 months fixed term contract)

AstraZeneca plc

Athlone

Sur place

EUR 90 000 - 115 000

Plein temps

Il y a 2 jours
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Résumé du poste

AstraZeneca plc is seeking a senior warehouse leader in Athlone to own the warehouse documentation, compliance and digital transformation across Drug Substance and Drug Product. You will shape product introduction, lead 3PL engagements and drive SAP S/4HANA and EWM readiness while safeguarding GMP standards.

You will guide cross-functional teams through change controls, audits and inspections, delivering measurable cost, speed and reliability gains that protect patients and accelerate therapies.

Qualifications

  • Minimum of 4 years' experience in a biopharmaceutical or other regulated manufacturing organization, including at least 2 years in a warehouse, materials or supply chain role.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience managing supplier or 3PL relationships.
  • Experience working with ERP/MRP systems, with SAP experience required.
  • Demonstrated experience leading QMS records, root cause investigations and CAPAs, and supporting regulatory and customer audits.
  • Demonstrated record of driving and delivering continuous improvement initiatives.
  • Track record of leading cross-functional projects or teams, with or without formal line management.

Responsabilités

  • Documentation and Compliance Leadership: Own the warehouse document lifecycle in EQV; approve and coach others on SOP quality and consistency; initiate and complete document updates with cross-functional collaboration to ensure clarity and compliance.
  • Strategic Workstreams and Process Improvement: Lead warehouse workstreams for strategic and project plans for process and material improvements, with accountability for plans, timelines and cost-saving outcomes; define and lead continuous improvement priorities both within the department and cross-functionally, and track realized benefits; lead GENBA programmes and coach the team to identify and deliver improvements.
  • QMS Ownership and Deviation Management: Own and author QMS records (change controls, deviations, CAPAs) and drive them to timely closure; lead root cause investigations and effective CAPAs for warehouse deviations, including complex, repeat or cross-site issues, in collaboration with cross-functional groups and external stakeholders as required.
  • Digital, Automation and AI Adoption: Lead the adoption of digital, automation and AI improvements for the warehouse, from business case and system enhancements to user adoption, driving measurable performance gains.
  • New Product Introduction and Project Support: Act as warehouse lead for the introduction of new products from start to finish; set storage and handling strategy and ensure all requirements are met; provide warehouse SME support for site-wide projects via review and approval of project plans and related documents; provide SME support for the materials department in projects related to warehousing processes.
  • 3PL and Supplier Engagement: Lead 3PL and supplier engagement for warehouse materials, including qualification, supplier change notifications and SCARs, partnering with Materials and Quality teams to sustain supply assurance.
  • SAP S/4HANA and EWM Readiness: Lead warehouse readiness for SAP S/4HANA and EWM, including process design, data readiness, testing, training and go-live support, ensuring a smooth transition and sustained adoption.
  • Audit and Inspection Readiness: Represent the warehouse in audits and inspections (e.g. HPRA, FDA, EMA), author and coordinate audit responses, and proactively strengthen systems to withstand scrutiny.
  • Storage Strategy: Support the warehouse storage strategy, including cold-chain and ambient storage requirements, safeguarding product quality throughout lifecycle.
  • KPI Reporting and Risk Management: Track and report warehouse KPIs and metrics (e.g. turnaround time and compliance trends); provide clear updates and recommendations to leadership; escape and manage risk, making or recommending decisions on process and compliance trade-offs; support wider site and Materials team priorities.
  • Mentoring and Training: Mentor and coach warehouse and materials colleagues, support onboarding and training, and help build a high-performing, curious and accountable team.

Connaissances

cGMP compliance
SAP ERP/MRP
QMS & CAPA leadership
Cross-functional leadership
Change controls, audits & inspections
Digital transformation & AI adoption
Project management
Supplier/3PL management

Formation

Biopharmaceutical or supply chain degree

Outils

SAP
Power BI
Power Platform

Description du poste

Are you ready to lead warehouse quality, documentation, and digital transformation that keeps life-changing medicines moving reliably from raw materials to released product? In this senior role at our Athlone manufacturing facility, you will own the warehouse processes that underpin both Drug Substance and Drug Product operations. As the site's lead technical and quality contact for the warehouse, you will partner with operations, technical experts and quality to turn best practice into standard practice and ensure every batch starts and finishes with confidence.

You will shape how we introduce new products, strengthen compliance, and modernize ways of working through automation, AI and SAP S/4HANA with EWM. Can you see yourself guiding cross-functional teams through change controls, audits and inspections while unlocking measurable cost, speed and reliability gains? Your decisions will protect patients and accelerate therapies in areas of high unmet need.

Accountabilities:
  • Documentation and Compliance Leadership: Own the warehouse document lifecycle in EQV; approve and coach others on SOP quality and consistency; initiate and complete document updates with cross-functional collaboration to ensure clarity and compliance.
  • Strategic Workstreams and Process Improvement: Lead warehouse workstreams for strategic and project plans for process and material improvements, with accountability for plans, timelines and cost-saving outcomes; define and lead continuous improvement priorities both within the department and cross-functionally, and track realized benefits; lead GENBA programmes and coach the team to identify and deliver improvements.
  • QMS Ownership and Deviation Management: Own and author QMS records (change controls, deviations, CAPAs) and drive them to timely closure; lead root cause investigations and effective CAPAs for warehouse deviations, including complex, repeat or cross-site issues, in collaboration with cross-functional groups and external stakeholders as required.
  • Digital, Automation and AI Adoption: Lead the adoption of digital, automation and AI improvements for the warehouse, from business case and system enhancements to user adoption, driving measurable performance gains.
  • New Product Introduction and Project Support: Act as warehouse lead for the introduction of new products from start to finish; set storage and handling strategy and ensure all requirements are met; provide warehouse SME support for site-wide projects via review and approval of project plans and related documents; provide SME support for the materials department in projects related to warehousing processes.
  • 3PL and Supplier Engagement: Lead 3PL and supplier engagement for warehouse materials, including qualification, supplier change notifications and SCARs, partnering with Materials and Quality teams to sustain supply assurance.
  • SAP S/4HANA and EWM Readiness: Lead warehouse readiness for SAP S/4HANA and EWM, including process design, data readiness, testing, training and go-live support, ensuring a smooth transition and sustained adoption.
  • Audit and Inspection Readiness: Represent the warehouse in audits and inspections (e.g. HPRA, FDA, EMA), author and coordinate audit responses, and proactively strengthen systems to withstand scrutiny.
  • Storage Strategy: Support the warehouse storage strategy, including cold-chain and ambient storage requirements, safeguarding product quality throughout lifecycle.
  • KPI Reporting and Risk Management: Track and report warehouse KPIs and metrics (e.g. turnaround time and compliance trends); provide clear updates and recommendations to leadership; escape and manage risk, making or recommending decisions on process and compliance trade-offs; support wider site and Materials team priorities.
  • Mentoring and Training: Mentor and coach warehouse and materials colleagues, support onboarding and training, and help build a high-performing, curious and accountable team.
Essential Skills/Experience:
  • Minimum of 4 years' experience in a biopharmaceutical or other regulated manufacturing organization, including at least 2 years in a warehouse, materials or supply chain role
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant
  • Experience managing supplier or 3PL relationships
  • Experience working with ERP/MRP systems, with SAP experience required
  • Demonstrated experience leading QMS records, root cause investigations and CAPAs, and supporting regulatory and customer audits
  • Demonstrated record of driving and delivering continuous improvement initiatives
  • Track record of leading cross-functional projects or teams, with or without formal line management
  • Strong organisational skills and attention to detail in managing GMP documentation and records
  • Strong stakeholder management and influencing skills, at both site and leadership level.
Desirable Skills/Experience:
  • Degree in Scientific or supply chain related field.
  • Experience using AI tools and digital systems to improve processes and ways of working
  • Excellent written and verbal skills and strong interpersonal skills
  • High level of proficiency in MS Office software including: Word, Copilot, Advanced Excel, Outlook, and PowerPoint; experience with data analysis and dashboard development, and with Power BI or Power Platform, is an advantage.
  • Experience leading or delivering transitions to new systems (e.g. SAP S/4HANA or EWM implementations), including data readiness, testing, training and user adoption
Why AstraZeneca:

Here, complex biology is translated into transformative medicines for people with rare and devastating diseases. We combine the agility of a biotech with the scale of a global biopharma, bringing unexpected teams together to spark bold thinking and practical solutions. You will work close to the science and close to patients, using modern platforms and digital tools to solve real operational challenges. We value kindness alongside ambition, provide autonomy to innovate, and invest in your growth so you can deliver meaningful, measurable impact that changes lives.

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.

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