Associate Director , External Manufacturing Lead Remote

Brief Description:

The Associate Director, 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

Contract Manufacturing Organisation (CMO) Relationship and Performance Management

• 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.

Leadership and Cross-functional Collaboration

• 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.

Planning and Execution

• 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.

Risk Management

• 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.

Innovation and Continuous Improvement

• 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.

Data Analysis and Reporting

• 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.

Supplier Compliance and Contract Management

• 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.

Required Knowledge, Skills, and Abilities

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.