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 radiotracer products.
Lead and participate in cross-functional teams to address issues, optimize processes, and improve overall external manufacturing performance.
Team Leadership and Development:
Lead, mentor, and develop a high-performing 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:
Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related field; an advanced degree (e.g., MBA, Master's 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 large-scale 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 cross-functional projects, and driving continuous improvement within a highly regulated environment.
Demonstrated success in cost optimization, vendor management, and managing large-scale manufacturing operations across multiple sites.
Skills & Competencies:
In-depth 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 problem-solving, negotiation, and conflict resolution skills.
Proven ability to manage complex, multi-site operations, prioritize tasks, and drive results in a fast-paced 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 $172,480.00-$258,720.00 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.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Application Deadline: May 08, 2025
