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 Healthcares key radiotracer ensuring highquality 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 lifesaving 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 highvolume production of three critical radiotracer 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 costeffective 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 speedtomarket 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 ontime 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.

CrossFunctional Collaboration:

• Work closely with internal departments such as Regulatory Affairs Supply Chain Quality and R&D to ensure alignment and seamless of external manufacturing activities.
• Collaborate with the commercial and marketing teams to ensure that production schedules meet demand forecasts for radiotracer products.
• Lead and participate in crossfunctional teams to address issues optimize processes and improve overall external manufacturing performance.

Team Leadership and Development:

• Lead mentor and develop a highperforming team that manages external manufacturing operations across multiple sites.
• Foster a culture of teamwork accountability and continuous learning within the external manufacturing team.
• Build a leadership pipeline within the team ensuring succession planning and development opportunities for top talent.

Qualifications:

Education:

• Bachelors degree in Engineering Pharmaceutical Sciences Life Sciences or a related field; an advanced degree (e.g. MBA Masters in Supply Chain or similar) preferred.

Experience:

• 12 years of experience in external manufacturing contract manufacturing or operations management within highly regulated industries such as pharmaceuticals biotechnology or radiopharmaceuticals.
• Proven track record of managing largescale external manufacturing networks particularly those producing critical radiopharmaceuticals or similar complex products.
• Extensive experience with 21 CFR 212 regulations and GMP as well as a deep understanding of radiopharmacy operations and Board of Pharmacy requirements.
• Strong experience leading teams managing crossfunctional projects and driving continuous improvement within a highly regulated environment.
• Demonstrated success in cost optimization vendor management and managing largescale manufacturing operations across multiple sites.

Skills & Competencies:

• Indepth knowledge of radiopharmaceutical manufacturing regulatory compliance and quality management.
• Exceptional leadership and interpersonal skills with the ability to inspire and manage large geographically distributed teams.
• Strong business acumen including financial management cost analysis and operational budgeting.
• Ability to collaborate across functions and build effective partnerships with external manufacturers and internal teams.
• Strong problemsolving negotiation and conflict resolution skills.
• Proven ability to manage complex multisite operations prioritize tasks and drive results in a fastpaced environment.
• Familiarity with SAP Oracle or other ERP systems is a plus.

Preferred Qualifications:

• Experience in leading external manufacturing operations for radiopharmaceuticals or highly regulated drug products.
• Proven ability to scale external manufacturing networks while maintaining regulatory compliance and product quality.
• Certification in project management or quality management is a plus.

For U.S. based positions only the pay range for this position is $172480.00$258720.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and location. In addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Application Deadline: May 08 2025