Senior Warehouse Quality & Digital Transformation Lead

Alexion Pharmaceuticals, Inc.

Athlone

Remote

EUR 90,000 - 120,000

Full time

2 days ago
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Job summary

AstraZeneca—Athlone site—is seeking a senior Warehouse Leader to own documentation, quality systems, and continuous improvement initiatives across Drug Substance and Drug Product operations. You will drive SAP S/4HANA and EWM readiness, lead audits, and implement AI and automation to boost performance while ensuring compliance and patient safety.

You will partner with operations, technical experts and quality to turn best practice into standard practice, mentoring teams and delivering cost

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
  • 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.

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Represent the warehouse in audits and inspections (e.g. HPRA, FDA, EMA), author and coordinate audit responses, and proactively strengthen systems to withstand scrutiny.
  • Support the warehouse storage strategy, including cold-chain and ambient storage requirements, safeguarding product quality throughout lifecycle.
  • Track and report warehouse KPIs and metrics (e.g. turnaround time and compliance trends); provide clear updates and recommendations to leadership; escalate and manage risk, making or recommending decisions on process and compliance trade-offs; support wider site and Materials team priorities.
  • Mentor and coach warehouse and materials colleagues, support onboarding and training, and help build a high-performing, curious and accountable team.

Skills

Biopharma experience
cGMP knowledge
ERP/MRP systems
QMS & CAPA leadership
Cross-functional leadership
Stakeholder management

Education

Degree in scientific or supply chain field

Tools

SAP

Job description

AstraZeneca—Athlone site—is seeking a senior Warehouse Leader to own documentation, quality systems, and continuous improvement initiatives across Drug Substance and Drug Product operations. You will drive SAP S/4HANA and EWM readiness, lead audits, and implement AI and automation to boost performance while ensuring compliance and patient safety.

You will partner with operations, technical experts and quality to turn best practice into standard practice, mentoring teams and delivering cost

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