Operations & Logistics (1)

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, and this role owns how our medicines physically and digitally move around the globe. The Associate Director, Distribution, Warehousing & Serialization – EU / International is the single accountable leader for the ex-US finished-goods network: third-party logistics (3PL) warehousing, GDP-compliant storage and transport, import/export and trade flows, and end-to-end serialization and traceability across the EU, UK, GCC and emerging markets.

This is a hands-on leadership role with real build-out in it. You will inherit a growing network and be expected to professionalize it: tighten 3PL governance and cost-to-serve, stand up serialization for new markets and new CMOs, and make compliance boringly reliable ahead of inspections and new product launches. You will lead a team (2–5 colleagues), own the associated operating budget and vendor relationships, and partner daily with Quality, Regulatory, Commercial, Finance and our EU/Int-based operations organization.

Success in year one looks like: a fully mapped and KPI-governed distribution network, zero GDP-critical audit findings, serialization live and stable in every market we sell into, and a launch-ready playbook for entering the next one.

Key Responsibilities

Distribution, Warehousing & Logistics

Own the ex-US distribution and warehousing network end to end — 3PLs, freight forwarders, wholesalers and local distribution partners across the EU/EEA, UK, Switzerland, GCC and other international markets — accountable for service, compliance and total cost-to-serve.
Lead 3PL and logistics provider strategy: sourcing and RFPs, selection, contract and rate negotiation, logistics/quality technical agreements, SLA and KPI design, monthly and quarterly business reviews, and continuous-improvement roadmaps.
Ensure GDP-compliant storage and transportation: qualified 15–25°C lanes, validated shipping solutions, temperature mapping and lane qualification, excursion management and disposition, and cold-chain risk assessment.
Own import/export and trade compliance in partnership with Regulatory and Finance: customs and HS classification, Incoterms, licences and permits (including controlled substances where applicable), post-Brexit GB/NI supply routes, and release-to-market handoffs with QP/QA.
Manage ex-US inventory deployment: 3PL strategy, shelf-life and expiry management, obsolescence and destruction governance, returns, and recall execution readiness.
Lead network and system projects: warehouse and 3PL transitions, new market set-up, network redesign, ERP/WMS/TMS integration, and supply-chain integration of acquired products and portfolios.

Serialization & Traceability

Own the international serialization strategy, operating model and compliance roadmap across all markets Azurity supplies.
Be the accountable business owner for EU FMD compliance under Delegated Regulation (EU) 2016/161 and DSCSA— EMVO onboarding and gateway management, national NMVS connections, commissioning and decommissioning, and product master data.
Deliver and sustain compliance in UK and Northern Ireland (MHRA requirements and Windsor Framework arrangements) and in international traceability regimes including Saudi Arabia (SFDA RSD / DTTS), UAE (Tatmeen), Turkey (İTS), Russia/CIS, LATAM (e.g. Brazil SNCM, Argentina ANMAT), APAC and India.
Own the Level 4/5 serialization repository (e.g. TraceLink, SAP ATTP, Antares/rfxcel, Systech, Movilitas) as business system owner: GS1 master data (GTIN, GLN, SSCC), EPCIS 1.2/2.0 data exchange with CMOs, 3PLs and trading partners, aggregation, and exception handling.
Lead serialization onboarding for every new CMO, packaging site, market and product launch — including artwork and labelling coordination with Regulatory and Packaging for 2D DataMatrix, unique identifier and anti-tampering device requirements.
Run alert and exception management with EMVO/NMVOs and partners: triage and investigate alerts, drive root cause and CAPA with CMOs, and systematically reduce false-positive and exception rates.
Maintain data integrity (ALCOA+) and validated state of serialization systems in line with GxP expectations, EU Annex 11 and 21 CFR Part 11.

Quality, Compliance & Inspection Readiness

Partner with Quality and Regulatory to maintain GDP compliance across the network (EU Guidelines 2013/C 343/01): deviations, CAPAs, change control, periodic self-inspection, and 3PL/wholesaler audit programmes.
Support the named Responsible Person(s) and QA on WDA/MIA licence footprints, release, quarantine, returns, suspected falsified medicines and recall processes — this role does not hold RP accountability but must be fully fluent in what it requires.
Own distribution and serialization SOPs, work instructions and training; maintain audit-ready documentation and represent the function in competent-authority, partner and customer inspections (e.g. HPRA, Swissmedic, MHRA, local ministries of health).

Leadership, Performance & Financials

Build, lead, coach and develop a team of 2–5 professionals; set objectives, manage performance and create bench strength in a fast-growing organization.
Own the ex-US distribution, warehousing and serialization operating budget; build business cases, deliver annual productivity and cost-to-serve savings, and manage accruals and vendor spend with Finance.

Required Skills and Experience

Bachelor's degree in supply chain, logistics, engineering, pharmacy, life sciences or a related field, preferred.
10+ years of pharmaceutical, biotech or healthcare supply chain experience, including 5+ years leading distribution, warehousing or logistics across multiple European/international markets.
Demonstrated ownership of EU GDP-regulated operations and of 3PL / wholesaler networks in more than one country — not oversight from a distance, but direct accountability for service and compliance outcomes.
Direct, hands-on accountability for serialization and track-and-trace in a MAH, virtual-manufacturing or CMO environment, including EU FMD/EMVO and at least one non-EU regime; working command of GS1 standards and EPCIS data exchange.
Experience as business owner or super-user of a Level 4 serialization platform (TraceLink, SAP ATTP, Antares/rfxcel, Systech, Movilitas or equivalent).
Cold-chain and temperature-controlled distribution expertise: qualified packaging, lane qualification, excursion investigation and disposition.
Proven vendor management and negotiation track record with 3PLs, CMOs and freight providers, including QTAs/logistics agreements and KPI governance.
Strong GxP quality fluency: deviations, CAPA, change control, validation, and audit/inspection support.
ERP fluency (Oracle preferred) plus WMS/TMS exposure, and strong analytical skills (advanced Excel; Power BI or similar) applied to cost and performance management.
People leadership experience with direct reports, and the credibility to influence senior stakeholders across Quality, Regulatory, Commercial and Finance.
Business-fluent English; effective working across time zones with US-based colleagues.
Eligible to work in Switzerland (Zug) or Ireland (Dublin), able to work hybrid from one of those hubs at least 3 days a week, and willing to travel approximately 10% (3PL sites, CMOs, partner and regulatory meetings).

Preferred Qualifications

Advanced degree or MBA in supply chain, operations or a scientific discipline.
Specialty pharma, generics or diversified-portfolio experience — many SKUs, many markets, frequent launches and transfers rather than a single blockbuster flow.
Experience launching products into new international markets, including first-time serialization go-lives in emerging markets (SFDA RSD, Tatmeen, İTS, CRPT, SNCM/ANMAT, iVEDA).
Familiarity with EU GDP Responsible Person requirements, or prior RP/deputy RP eligibility (valued for fluency; RP accountability sits with Quality in this structure).
Experience integrating acquired portfolios or executing product/site transfers between 3PLs and CMOs.
Controlled-substance and narcotics distribution experience, and country-specific permit management.
GS1 certification, Lean Six Sigma (Green or Black Belt), or equivalent process-excellence credentials.preferred.
Experience with artwork/labelling management systems (e.g. Veeva Vault) and computer system validation of serialization solutions.
Comfort operating in a private-equity-backed, high-growth, build-as-you-go environment.

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Associate Director

Distribution, Warehousing & Serialization, EU / International

Azurity Pharmaceuticals

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