Quality Director, Japan and Emerging Markets Distribution (Remote)

If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description:
The International and Partner Markets are a key area of commercial growth within Jazz. The purpose of this role is to lead and influence Quality strategy for the distribution and supply of medicinal products into these markets and across multiple Jazz partnerships. The scope of this appointment includes Jazz Affiliate offices in Canada, Australia, and Japan, and commercial distribution in over 40 countries via a number of marketing partners. This is a global role covering central and eastern Europe and all other regions except North America.
Key responsibilities include:
To oversee and ensure consistent quality systems across Jazz partner marketsTo develop strong partnerships with the International Partner Markets senior leadership teamBuild relationships with commercial marketing and distribution partnersManage the Japan quality function and ensure commercial readiness for product launchIn conjunction with the Sr Director, In-Market Quality, facilitate successful implementation of the Jazz quality roadmapLead Brand Protection investigations for these markets for potentially falsified medicinesIdentify and resolve potential supply risksDrive quality issue resolutionsInteract with health authorities to communicate a consistent quality-driven approach for Jazz productsThis role reports to the Senior Director, In-Market & Affiliate Quality.
Essential Functions
Lead the establishment of the Jazz global Quality System for new geographiesNuture positive and collaborative relationships with key stakeholdersCreate suitable roadmap plans for longer-term improvement strategiesDrive continual improvement and operational excellenceActively champion quality, identify vulnerabilities and drive corrective/preventive actionsSupport new submissions and early access programsEnsure preparedness for local inspectionsResponsible for ensuring products remain distributed in accordance with respective licenses and within applicable Jazz global and local regulatory requirementsEstablish and actively monitor Key quality Performance Indicators to facilitate continual improvementOperate in accordance with Jazz values of Integrity, Collaboration, Passion, Innovation and the Pursuit of ExcellenceRequired Knowledge, Skills, and Abilities
Affiliate office quality operations within a global supply chainPartner management for distribution and supplyStrong knowledge and understanding of pharmaceutical supply chains across differing geographies and dosage formsExpertise in the Japanese market and pharmaceutical expectationsUnderstanding of Managed Access Programs/Early Access ProgramsPrevious experience of QP/RP responsibilities would be an advantageCross-functional working at all levelsRisk ManagementPragmatic and flexible approachConflict managementLead Auditor trained an advantageExcellent command of EnglishRequired/Preferred Education and Licenses
Bachelor Degree in science related discipline, post-graduate preferredRP or QP eligibility preferredDescription of Physical Demands
Constantly operating a computer, printer, telephone and other similar office machineryTravel will be requiredJazz Pharmaceuticals is an Equal Opportunity Employer.
Remote working/work at home options are available for this role.