Associate External Manufacturing Leader

GE HealthCare

3d • $105,600 - $158,400

About The Position

The Associate External Manufacturing Leader provides tactical support across the radiotracer production network. Reporting to the External Manufacturing Leader (EML), this role executes and monitors daily operations across the External Manufacturing network as assigned by the EML. It helps ensure compliance, quality, and on-time delivery from external manufacturing partners while contributing to the External Manufacturing Organization’s strategic goals and initiatives.

The role works with external sites and internal cross-functional teams and requires strong organization, comfort with regulated processes, and collaboration. The position supports operational issue resolution, production and shipment tracking, compliance and quality activities, partner coordination, performance reporting, logistics, and continuous improvement. It may also support new partner onboarding, continuity of supply, and the expansion of manufacturing capabilities.

Requirements

• At least 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment.
• Familiarity with GMP, 21 CFR 212, and/or Board of Pharmacy requirements.
• Detail-oriented, with strong organizational and follow-up skills.
• Ability to work independently while keeping leadership informed of key issues.
• Strong communication and coordination skills across functions and external partners.
• Comfort handling production data, SOPs, and documentation.
• Proficiency in Microsoft Office, including Excel and PowerPoint.
• Bachelor’s degree preferred in Life Sciences, Chemistry, Engineering, or a related field; equivalent experience is considered.

Nice To Haves

• Experience in pharmaceuticals, biotech, or radiopharmaceuticals.
• Experience supporting or working within a multi-site manufacturing network.
• Experience with ERP systems such as SAP or Oracle.
• Experience in radiopharmaceutical or radiotracer production environments.
• Familiarity with lean manufacturing principles or continuous improvement tools.
• Exposure to quality systems or regulatory audits.

Responsibilities

• Collaborate with site managers and manufacturing leadership to resolve operational challenges and implement corrective actions.
• Track production activities, documentation, and radiotracer shipments to support accurate and timely delivery.
• Support root cause investigations for operational deviations with Quality and Regulatory teams.
• Maintain documentation, including batch records, change controls, and issue logs for assigned manufacturing sites.
• Provide regular performance reports to the External Manufacturing Leader and senior leadership.
• Support the External Manufacturing Leader in leading regular business reviews with external partners.
• Acknowledge, prioritize, and communicate failure or delay notifications so internal stakeholders and customers are informed simultaneously.
• Monitor site-level compliance with GMP and 21 CFR 212 requirements.
• Conduct checklist-driven readiness reviews for new manufacturing locations, inspections, audits, and partner reviews.
• Support new customer go-live supply planning and operational supply plans.
• Assist with review and tracking of CAPAs, deviations, and SOP updates as directed by the External Manufacturing Leader.
• Serve as a day-to-day liaison between regional manufacturing partners and internal teams, including External Manufacturing, Materials Management, QA, MSAT, R&D, Service, and Logistics.
• Attend and document regular calls or check-ins with assigned CMOs or manufacturing partners.
• Escalate issues or risks to the External Manufacturing Leader and suggest mitigation steps.
• Track vendor performance metrics, including delivery, quality, and throughput, and support data collection and reporting.
• Integrate new AI tools and Power BI dashboards to improve real-time external manufacturing visibility.
• Assist with onboarding new regional manufacturing partners, including documentation and logistics setup.
• Facilitate continuity of supply across CMO partners when a failure occurs.
• Identify tactical operational improvement opportunities and propose solutions to drive efficiency.
• Help document and implement SOPs and best practices that enhance speed, compliance, or cost-effectiveness.
• Participate in lean or Six Sigma-based initiatives to reduce waste and improve process flow.
• Assist in developing long-term strategies and expanding manufacturing capabilities.

Benefits

• Competitive benefits package including medical, dental, and vision coverage.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.
• May be eligible for performance-based incentive compensation, including cash bonuses and/or long-term incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level