AD, External Manufacturing Lead (Remote) (Hiring Immediately)

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Brief Description:

The External Manufacturing Lead (EML) has overall responsibility for the performance of an external Contract Manufacturing Organisation (CMO) portfolio for Jazz commercial products. The EML will be required to build and manage strong business relationships with the CMO and will act as the primary point of contact for all performance, contractual compliance and supply related issues.

The EML will lead cross-functional high performing teams, who have shared accountability for the performance of the CMO. The EML will develop and agree manufacture and supply plans with the CMO in alignment with Technical Operations strategy and will oversee the execution of the CMO’s operations and be responsible for the delivery of robust, quality and cost-effective supply, on time and on budget.

The EML will be responsible for the periodic assessment and improvement of the CMOs performance through monitoring and reporting of best-in-class metrics and KPIs, risk identification and mitigation plans, and continuous improvements initiatives to ensure operational efficiency and effectiveness in the supply chain while maximizing sustainable practices that support Jazz's Technical Operations strategy.

Essential Functions/Responsibilities

• Build strong relationships with CMO to develop mutually beneficial and collaborative relationships that deliver long-term value creation and foster a culture of continuous improvements and innovation.
• Responsible for overseeing and managing all aspects of the business relationship, their development and performance against defined KPIs, to ensure CMOs meet contractual obligations and performance standards, such as quality, cost, delivery time and compliance, in alignment with Jazz’s Technical Operations strategy.
• Lead Business Reviews Meetings (BRM) and ensures output from the meetings is documented in alignment with Jazz’s procedures.
• Proactively manage and communicate CMO performance, ensuring timely resolution of issues in alignment with business objectives.
• Partner with CMOs to define and implement multiyear performance improvement initiatives.

• Lead cross-functional teams and is accountable for the team’s performance and day to day activity to ensure that supply plans, assignments and projects are delivered to agreed standards.
• Lead cross-functional teams in the selection, onboarding, and management of CMOs performance to support Jazz’s Technical Operations strategy.
• Acts as the primary point of contact and escalation point when required for all CMOs business, performance and supply-related issues. Drives plans, oversees execution of activity and ensures timely resolution of issues to mitigate supply disruptions.
• Set objectives and multiyear plans for assigned CMOs, ensuring alignment with broader organizational goals.

• Develop and oversee manufacturing and supply plans, for Drug Substance, bulk Drug Product and Finished Product per the agreed plan, on time and on budget.
• Lead internal and external meetings, drive agendas, and prioritize issues for discussion to enhance decision-making and execution.
• Develop cost plan for all required activities ensuring budget is in place and approved. Tracks and reports performance against budget.
• Ensures cross functional partnerships and resources are leveraged effectively, with accountability, to achieve program objectives in alignment with corporate objectives.
• Maintain a flexible planning mindset to quickly adapt to shifting priorities and unforeseen supply chain challenges.
• Collaborate with stakeholders to ensure seamless transition from development to commercial manufacturing.

• Lead the proactive identification and documentation of supply risks and opportunities for the assigned CMOs. Develop robust mitigation plans and oversee implementation of action plans to mitigate supply disruption.
• Communicate, escalate supply and performance risks to key senior management as appropriate.
• Supports the generation of business continuity plans for Jazz’s external network.

• Foster a culture of continuous improvement and innovation within the team and the CMO to enhance product quality, reduce costs, and improve supply chain efficiency and sustainability.
• Collaborate with CMO business partners and key stakeholders to share best practices, develop opportunities for improvement and drive excellence in external manufacturing.

• Support developing and implementing best practices and best-in-class metrics / KPI’s that enhance CMO performance and Technical Operations performance reporting capability.
• Utilize data analytics to monitor supplier performance metrics, identify trends and areas for improvement.
• Prepare and present reports on CMO performance to senior management and other stakeholders as required.

• Own and oversee Master Services Agreements with CMOs, ensuring alignment with contractual obligations and business needs.
• Partner with Quality, Legal, and Procurement and other key stakeholder as required to ensure supplier relationships are governed by appropriate quality and legal agreements.
• Lead CMO governance, ensuring compliance with company policies, regulatory requirements, and industry best practices.

1. External Manufacturing & Supplier Relationship Management

• Strong background in managing Contract Manufacturing Organizations (CMOs) or External Vendors within the pharmaceutical/biopharmaceutical industry.
• Experience in overseeing supply agreements, contractual compliance, and CMO performance management.
• Ability to build and maintain strategic partnerships with external suppliers, ensuring alignment with business objectives.
• Proven track record of driving supplier performance improvements and resolving supply-related challenges.

1. Supply Chain & Operations Management

• Hands-on experience in end-to-end supply chain management, including demand planning, production scheduling, and inventory management.
• Knowledge of manufacturing and distribution processes for drug substances, bulk drug products, and finished goods.
• Experience working with cross-functional teams and develop production plans to ensure delivery of supply while managing risks.

1. Leadership & Cross-Functional Team Management

• Experience leading and managing cross-functional teams, and key stakeholders.
• Proven ability to set and measure clear objectives, drive accountability, and foster a high-performance culture.
• Strong decision-making skills, particularly in a fast-paced and complex manufacturing environment.

1. Risk Management & Continuous Improvement

• Experience in identifying, documenting and developing risk mitigating plans in supply chain and external manufacturing operations.
• Familiarity with business continuity planning for external vendors, including contingency planning for supply disruptions.
• Experience driving continuous improvement initiatives, including cost reduction, process optimization, and operational efficiency improvements.

1. Compliance, Quality & Regulatory Knowledge

• Understanding of GMP (Good Manufacturing Practices), regulatory compliance, and industry standards for pharmaceutical manufacturing.
• Experience working with Quality, Regulatory Affairs, and Legal teams to ensure vendor compliance with company policies and industry regulations.
• Familiarity with supplier audits, quality agreements, and deviation/change control management.

1. Financial & Contractual Acumen

• Experience in budget management, cost forecasting, and financial tracking related to external manufacturing.
• Understanding of contract negotiation, supplier agreements, and procurement processes.
• Ability to assess financial ris