Manager, Distribution, Warehousing & Serialization – EU / International

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

"Azurity roles are office based and are generally require individuals to be in office Tuesday through Thursday with Monday and Friday as optional days."

About the Role

Azurity is scaling its international business from its European hubs in Zug, Switzerland and Dublin, Ireland. The Manager, Distribution, Warehousing & Serialization – EU / International is the operational engine of our ex-US finished-goods supply chain: the person who makes third-party logistics (3PL) warehousing, GDP-compliant transport, import/export flows and serialization actually run, market by market and shipment by shipment.

Reporting to the Associate Director, Distribution, Warehousing & Serialization – EU / International, you will own defined countries, partners and processes within that mandate. Expect a hands-on role in a lean, fast-growing team: you will be the day-to-day point of contact for our 3PLs and freight partners, the person who runs serialization onboarding and exception management, and the one who investigates the temperature excursion or NMVS alert rather than delegating it. This is a strong platform for someone ready to step up from a specialist or supervisory role into broader multi-market ownership.

Success in year one looks like: 3PL performance measured and improving against agreed KPIs, serialization live and stable in every assigned market with alerts closed inside target, clean and audit-ready documentation, and no supply interruption caused by a distribution or traceability issue on your watch.

Key Responsibilities

Distribution, Warehousing & Logistics

• Manage day-to-day ex-US distribution operations across assigned markets — 3PL warehouses, freight forwarders, wholesalers and local distribution partners in the EU/EEA, UK, Switzerland, GCC and other international markets.
• Act as primary operational contact for 3PL and logistics partners: order and shipment execution, issue resolution, performance tracking against SLAs/KPIs, monthly operational reviews, and preparation of materials for quarterly business reviews.
• Execute GDP-compliant storage and transport: qualified 2–8°C and 15–25°C lanes, validated shipping solutions, temperature monitoring, and first-line investigation and disposition of excursions with QA.
• Coordinate import/export activity with partners, brokers and Regulatory: shipping documentation, customs and HS classification support, Incoterms application, permits and licences, and GB/NI supply-route requirements.
• Maintain ex-US inventory health: obsolescence and destruction paperwork, returns processing, and recall readiness support.
• Support network and system projects as workstream lead — 3PL and warehouse transitions, new market set-up, ERP/WMS data and interface testing, and integration of newly acquired products.

Serialization & Traceability

• Run day-to-day serialization operations across assigned markets, ensuring every product is compliant before it ships.
• Execute EU FMD obligations under Delegated Regulation (EU) 2016/161: EMVO gateway and NMVS uploads, product master data, commissioning and decommissioning, and pack-level data accuracy.
• Support compliance in UK and Northern Ireland (MHRA requirements and Windsor Framework arrangements) and in international regimes including Saudi Arabia (SFDA RSD / DTTS), UAE (Tatmeen), Turkey (İTS), Russia/CIS, LATAM (e.g. Brazil SNCM, Argentina ANMAT), APAC and India.
• Operate the Level 4 serialization platform (e.g. TraceLink, SAP ATTP, Antares/rfxcel, Systech, Movilitas) as super-user: GS1 master data (GTIN, GLN, SSCC), EPCIS file exchange with CMOs and 3PLs, aggregation data, and exception handling.
• Coordinate serialization onboarding for new CMOs, markets and product launches — connection testing, data mapping, trial runs, and artwork/labelling checks with Regulatory and Packaging for 2D DataMatrix, unique identifier and anti-tampering device requirements.
• Own first-line alert and exception management with EMVO/NMVOs, CMOs and partners: triage, investigate, document, escalate where needed, and drive down repeat causes.
• Maintain accurate, complete records in line with data integrity expectations (ALCOA+), EU Annex 11 and 21 CFR Part 11.

Quality, Compliance & Inspection Readiness

• Work with Quality and Regulatory to keep the network GDP compliant (EU Guidelines 2013/C 343/01): raise and progress deviations, contribute to CAPAs and change controls, and support self-inspections and 3PL audits.
• Support the named Responsible Person(s) and QA on release, quarantine, returns, suspected falsified medicines and recall processes — this role does not hold RP accountability but must know exactly what it requires.
• Draft and maintain SOPs, work instructions and training records for distribution and serialization processes; keep documentation inspection-ready and support competent-authority and partner audits (e.g. HPRA, Swissmedic, MHRA, local ministries of health).

Performance, Reporting & Collaboration

• Produce and maintain the operational KPI reporting pack — OTIF/DIFOT, order cycle time, inventory turns and days of supply, excursion rate, serialization exception and alert closure rates — and flag trends early with recommended actions.
• Support the Associate Director on budget tracking, freight and warehousing cost analysis, invoice and accrual queries, and business cases for improvement projects.
• Identify and deliver continuous-improvement opportunities in process, cost and data quality; lead small projects independently.
• Collaborate across Quality, Regulatory, Commercial, Finance, Planning and US-based global supply chain colleagues.

Required Skills and Experience

• Bachelor's degree in supply chain, logistics, engineering, pharmacy, life sciences or a related field.
• 5+ years of pharmaceutical, biotech or healthcare supply chain experience, with at least 3 years in distribution, warehousing, logistics or serialization operations.
• Working experience of EU GDP-regulated distribution and of day-to-day 3PL or wholesaler coordination in more than one country.
• Hands-on serialization / track-and-trace experience in a MAH, virtual-manufacturing or CMO environment, including EU FMD/EMVO; practical familiarity with GS1 standards (GTIN, GLN, SSCC) and EPCIS data exchange.
• User-level or super-user competence on a Level 4 serialization platform (TraceLink, SAP ATTP, Antares/rfxcel, Systech, Movilitas or equivalent).
• Cold-chain and temperature-controlled distribution exposure: qualified packaging, temperature monitoring, and excursion documentation and investigation.
• Solid GxP quality fluency: deviations, CAPA, change control, SOP authoring, and audit support.
• ERP experience (SAP preferred; MM/SD/EWM or equivalent) and strong analytical skills — advanced Excel essential, Power BI or similar an advantage.
• Well organised and detail-driven under time pressure, with the judgement to know what to escalate and the initiative to resolve the rest independently.
• Business-fluent English; effective written and verbal communication with external partners and with US-based colleagues across time zones.
• Eligible to work in Ireland (Dublin), able to work hybrid from one of this hub, and willing to travel approximately 10% (3PL sites, CMOs, partner meetings).

Preferred Qualifications

• Specialty pharma or generics experience — many SKUs, many markets, frequent launches and product transfers rather than a single high-volume flow.
• Involvement in a serialization go-live in a non-EU market (SFDA RSD, Tatmeen, İTS, CRPT, SNCM/ANMAT, iVEDA) or in an EMVO onboarding project.
• Experience supporting a 3PL selection, warehouse transition or new-market distribution set-up.
• Familiarity with EU GDP Responsible Person requirements (RP accountability sits with Quality in this structure).
• Exposure to controlled-substance or narcotics distribution and country permit management.
• WMS/TMS exposure, artwork/labelling systems (e.g. Veeva Vault), or participation in computer system validation of serialization solutions.
• APICS CPIM/CSCP, GS1 training, or Lean Six Sigma (Yellow/Green Belt).
• An additional European language (German, French, Spanish, Italian or Dutch).
• Comfort operating in a lean, high-growth, build-as-you-go environment where scope evolves

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