[Urgent] Associate Director , External Manufacturing Lead(Remote)

Jazz Pharmaceuticals
The City
1 day ago
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If you are a current Jazz employee please apply viathe Internal Career site. Ensure all your application informationis up to date and in order before applying for this opportunity.Jazz Pharmaceuticals is a global biopharma company whose purpose isto innovate to transform the lives of patients and their families.We are dedicated to developing life-changing medicines for peoplewith serious diseases — often with limited or no therapeuticoptions. We have a diverse portfolio of marketed medicines,including leading therapies for sleep disorders and epilepsy, and agrowing portfolio of cancer treatments. Our patient-focused andscience-driven approach powers pioneering research and developmentadvancements across our robust pipeline of innovative therapeuticsin oncology and neuroscience. Jazz is headquartered in Dublin,Ireland with research and development laboratories, manufacturingfacilities and employees in multiple countries committed to servingpatients worldwide. Please visitwww.jazzpharmaceuticals.comformore information. Brief Description: The Associate Director,External Manufacturing Lead (EML) has overall responsibility forthe performance of an external Contract Manufacturing Organisation(CMO) portfolio for Jazz commercial products. The EML will berequired to build and manage strong business relationships with theCMO and will act as the primary point of contact for allperformance, contractual compliance and supply related issues. TheEML will lead cross-functional high performing teams, who haveshared accountability for the performance of the CMO. The EML willdevelop and agree manufacture and supply plans with the CMO inalignment with Technical Operations strategy and will oversee theexecution of the CMO’s operations and be responsible for thedelivery of robust, quality and cost-effective supply, on time andon budget. The EML will be responsible for the periodic assessmentand improvement of the CMOs performance through monitoring andreporting of best-in-class metrics and KPIs, risk identificationand mitigation plans, and continuous improvements initiatives toensure operational efficiency and effectiveness in the supply chainwhile maximizing sustainable practices that support Jazz'sTechnical Operations strategy. Essential Functions/ResponsibilitiesContract Manufacturing Organisation (CMO) Relationship andPerformance Management Build strong relationships with CMO todevelop mutually beneficial and collaborative relationships thatdeliver long-term value creation and foster a culture of continuousimprovements and innovation. Responsible for overseeing andmanaging all aspects of the business relationship, theirdevelopment and performance against defined KPIs, to ensure CMOsmeet contractual obligations and performance standards, such asquality, cost, delivery time and compliance, in alignment withJazz’s Technical Operations strategy. Lead Business ReviewsMeetings (BRM) and ensures output from the meetings is documentedin alignment with Jazz’s procedures. Proactively manage andcommunicate CMO performance, ensuring timely resolution of issuesin alignment with business objectives. Partner with CMOs to defineand implement multiyear performance improvement initiatives.Leadership and Cross-functional Collaboration Lead cross-functionalteams and is accountable for the team’s performance and day to dayactivity to ensure that supply plans, assignments and projects aredelivered to agreed standards. Lead cross-functional teams in theselection, onboarding, and management of CMOs performance tosupport Jazz’s Technical Operations strategy. Acts as the primarypoint of contact and escalation point when required for all CMOsbusiness, performance and supply-related issues. Drives plans,oversees execution of activity and ensures timely resolution ofissues to mitigate supply disruptions. Set objectives and multiyearplans for assigned CMOs, ensuring alignment with broaderorganizational goals. Planning and Execution Develop and overseemanufacturing and supply plans, for Drug Substance, bulk DrugProduct and Finished Product per the agreed plan, on time and onbudget. Lead internal and external meetings, drive agendas, andprioritize issues for discussion to enhance decision-making andexecution. Develop cost plan for all required activities ensuringbudget is in place and approved. Tracks and reports performanceagainst budget. Ensures cross functional partnerships and resourcesare leveraged effectively, with accountability, to achieve programobjectives in alignment with corporate objectives. Maintain aflexible planning mindset to quickly adapt to shifting prioritiesand unforeseen supply chain challenges. Collaborate withstakeholders to ensure seamless transition from development tocommercial manufacturing. Risk Management Lead the proactiveidentification and documentation of supply risks and opportunitiesfor the assigned CMOs. Develop robust mitigation plans and overseeimplementation of action plans to mitigate supply disruption.Communicate, escalate supply and performance risks to key seniormanagement as appropriate. Supports the generation of businesscontinuity plans for Jazz’s external network. Innovation andContinuous Improvement Foster a culture of continuous improvementand innovation within the team and the CMO to enhance productquality, reduce costs, and improve supply chain efficiency andsustainability. Collaborate with CMO business partners and keystakeholders to share best practices, develop opportunities forimprovement and drive excellence in external manufacturing. DataAnalysis and Reporting Support developing and implementing bestpractices and best-in-class metrics / KPI’s that enhance CMOperformance and Technical Operations performance reportingcapability. Utilize data analytics to monitor supplier performancemetrics, identify trends and areas for improvement. Prepare andpresent reports on CMO performance to senior management and otherstakeholders as required. Supplier Compliance and ContractManagement Own and oversee Master Services Agreements with CMOs,ensuring alignment with contractual obligations and business needs.Partner with Quality, Legal, and Procurement and other keystakeholder as required to ensure supplier relationships aregoverned by appropriate quality and legal agreements. Lead CMOgovernance, ensuring compliance with company policies, regulatoryrequirements, and industry best practices. Required Knowledge,Skills, and Abilities 1. External Manufacturing & SupplierRelationship Management Strong background in managing ContractManufacturing Organizations (CMOs) or External Vendors within thepharmaceutical/biopharmaceutical industry. Experience in overseeingsupply agreements, contractual compliance, and CMO performancemanagement. Ability to build and maintain strategic partnershipswith external suppliers, ensuring alignment with businessobjectives. Proven track record of driving supplier performanceimprovements and resolving supply-related challenges. 2. SupplyChain & Operations Management Hands-on experience in end-to-endsupply chain management, including demand planning, productionscheduling, and inventory management. Knowledge of manufacturingand distribution processes for drug substances, bulk drug products,and finished goods. Experience working with cross-functional teamsand develop production plans to ensure delivery of supply whilemanaging risks. 3. Leadership & Cross-Functional TeamManagement Experience leading and managing cross-functional teams,and key stakeholders. Proven ability to set and measure clearobjectives, drive accountability, and foster a high-performanceculture. Strong decision-making skills, particularly in afast-paced and complex manufacturing environment. 4. RiskManagement & Continuous Improvement Experience in identifying,documenting and developing risk mitigating plans in supply chainand external manufacturing operations. Familiarity with businesscontinuity planning for external vendors, including contingencyplanning for supply disruptions. Experience driving continuousimprovement initiatives, including cost reduction, processoptimization, and operational efficiency improvements. 5.Compliance, Quality & Regulatory Knowledge Understanding of GMP(Good Manufacturing Practices), regulatory compliance, and industrystandards for pharmaceutical manufacturing. Experience working withQuality, Regulatory Affairs, and Legal teams to ensure vendorcompliance with company policies and industry regulations.Familiarity with supplier audits, quality agreements, anddeviation/change control management. 6. Financial & ContractualAcumen Experience in budget management, cost forecasting, andfinancial tracking related to external manufacturing. Understandingof contract negotiation, supplier agreements, and procurementprocesses. Ability to assess financial risks and optimize costefficiency in external supply partnerships. 7. Data Analytics &Performance Management Experience using data analytics to monitorsupplier performance, track KPIs, and drive data-drivendecision-making processes. Ability to develop and presentperformance reports to senior management and key stakeholders.Familiar with supply chain and manufacturing software/tools (e.g.,SAP, ERP systems, or other planning tools) preferred. PreferredIndustry & Functional Experience Industry: Pharmaceutical,Biotech, or Life Sciences (experience in highly regulatedenvironments preferred). Functional Areas: Supply Chain,Manufacturing Operations, Procurement, Quality Assurance, orExternal Vendor Management. Global Experience: Working withinternational CMOs, suppliers, or manufacturing networks acrossmultiple regions. Jazz Pharmaceuticals is an equalopportunity/affirmative action employer and all qualifiedapplicants will receive consideration for employment without regardto race, color, religion, sex, national origin, disability status,protected veteran status, or any characteristic protected by law.The successful candidate will also be eligible to participate invarious benefits offerings, including, but not limited to, medical,dental and vision insurance, retirement savings plan, and flexiblepaid vacation. For more information on our Benefits offeringsplease click here:https://careers.jazzpharma.com/benefits.html.Remote working/work at home options are available for thisrole.

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