Job Description Summary

GE Healthcare is seeking an experienced and visionary Senior Director of ExternalManufacturing to lead a network of over 50 external manufacturing sites across the U.S. and Canada. This critical role will oversee the production of three of GE Healthcare's key radiotracer drugs, ensuring high-quality standards, compliance, safety, speed, and cost efficiency. The Senior
Director will be responsible for shaping and executing the strategy for external manufacturing operations, driving performance, optimizing the supply chain, and fostering strong relationships with external partners in the production of life-saving radiopharmaceuticals.

Job Description

Key Responsibilities:

Strategic Leadership and Network Management:

• Lead and oversee a network of 50+ external manufacturing sites in the U.S. and Canada, ensuring the high-volume production of three critical radiotracer drugs for GE Healthcare.
• Define the overall strategy for managing external manufacturing, including risk management, performance optimization, and compliance.
• Provide leadership and direction to a team responsible for managing all external manufacturing relationships, ensuring alignment with corporate goals, and operational efficiency.
• Ensure that external manufacturers adhere to the highest standards of quality, safety, and compliance with regulatory requirements.

Relationship Management:

• Build and maintain strong, effective relationships with external manufacturing partners, including contract manufacturing organizations (CMOs), radiopharmacies, and production sites.
• Negotiate and manage vendor contracts and performance agreements, ensuring cost-effective operations without compromising quality or safety.
• Foster a culture of collaboration, accountability, and continuous improvement with external partners.

Safety, Quality, and Compliance:

• Ensure all external manufacturing operations comply with 21 CFR 212, GMP regulations, FDA guidelines, and other industry standards, particularly in the production of radiopharmaceuticals.
• Drive initiatives to ensure the safe handling and production of radiotracers, adhering to environmental, health, and safety (EHS) standards and Board of Pharmacy requirements.
• Oversee compliance to stringent regulatory frameworks, ensuring all external partners follow the required guidelines for radiopharmaceuticals.
• Monitor and ensure that external sites meet the highest levels of quality, implement corrective actions where necessary, and continuously improve processes to meet regulatory standards.

Operational Excellence & Performance:

• Lead initiatives to improve operational efficiency, reduce costs, and enhance speed-to-market across the external manufacturing network.
• Work with external partners to implement lean manufacturing principles and continuous improvement practices that streamline production processes and improve productivity.
• Oversee key performance metrics, ensuring that external manufacturing sites meet or exceed benchmarks for delivery, quality, cost, and compliance.
• Monitor capacity planning, inventory management, and on-time delivery of radiotracers, proactively addressing any supply chain or manufacturing risks

Financial and Cost Management:

• Develop and manage budgets for external manufacturing operations, focusing on cost control and budget compliance across 50+ sites.
• Lead cost optimization efforts by identifying opportunities for savings while ensuring manufacturing quality and regulatory compliance are not compromised.
• Analyze production costs, negotiate contracts with external partners, and identify opportunities for cost reduction and efficiency improvements.

Risk Management:

• Identify and mitigate risks associated with the external manufacturing network, including production capacity, regulatory compliance, and supply chain disruptions.
• Implement risk mitigation strategies and develop contingency plans to ensure continuous production and timely delivery of radiotracers to meet market demand.
• Proactively monitor potential risks in the supply chain, addressing challenges such as delays, quality deviations, or changes in regulatory requirements.

Cross-Functional Collaboration:

• Work closely with internal departments such as Regulatory Affairs, Supply Chain, Quality, and R&D to ensure alignment and seamless execution of external manufacturing activities.
• Collaborate with the commercial and marketing teams to ensure that production schedules meet demand forecasts for radiotr