Associate External Manufacturing Leader

GE HealthCare; United States; On-site; USD 105,600 - 158,400; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401(k) plan

Life insurance

Tuition reimbursement

Job summary

GE HealthCare is seeking an Associate External Manufacturing Leader to provide tactical support across their radiotracer production network. Responsibilities include ensuring compliance, quality, and on-time delivery from external partners, while collaborating with site managers to resolve operational challenges.

The ideal candidate should have a Bachelor’s degree in a relevant field and at least three years of experience in manufacturing or operations within a regulated environment. This position offers a competitive salary range and a comprehensive benefits package.

Qualifications

• 3+ years of experience in a manufacturing, operations, or quality support role.
• Familiarity with GMP and 21 CFR 212 requirements.
• Experience in a multi-site manufacturing network is a plus.

Responsibilities

• Collaborate with site managers to resolve operational challenges.
• Monitor site-level compliance with GMP and regulatory requirements.
• Track vendor performance metrics and support reporting.

Skills

Detail-oriented

Organizational skills

Communication skills

Proficient in Microsoft Office

Experience with ERP systems

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field

Tools

SAP

Oracle

Job description

The Associate External Manufacturing Leader will provide tactical support across the radiotracer production network. It involves executing and monitoring daily operations across the External Manufacturing network as assigned by the External Manufacturing Leader, ensuring compliance, quality, and on-time delivery from external manufacturing partners while contributing to the strategic goals and initiatives of the External Manufacturing Organization.

Key Responsibilities

Operational Support

• Collaborate with site managers and manufacturing leadership to resolve operational challenges and implement corrective actions. Track production activities, documentation, and shipments of radiotracers to ensure accurate and timely delivery.
• Support root cause investigations for operational deviations, working closely with the 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, ensuring simultaneous awareness among all internal stakeholders and customers.

Compliance & Quality Execution

• 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 in the 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 (e.g., 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, along with suggested mitigation steps.

Logistics & Coordination

• Track vendor performance metrics (delivery, quality, 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 of new regional manufacturing partners, including documentation and logistics setup.
• Facilitate the continuity of supply across various CMO partners when a failure occurs.

Process & Continuous Improvement

• Identify areas for operational improvement at the tactical level 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 the development of long‑term strategies and expansion of manufacturing capabilities.

Required Qualifications

Education

• Bachelor’s degree preferred in Life Sciences, Chemistry, Engineering, or related field. Equivalent experience considered.

Experience

• Minimum of 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment (pharmaceuticals, biotech, radiopharmaceuticals preferred).
• Familiarity with GMP, 21 CFR 212, and/or Board of Pharmacy requirements.
• Experience supporting or working within a multi‑site manufacturing network is a plus.

Skills & Competencies

• Detail‑oriented with strong organizational and follow‑up skills.
• Able to work independently while keeping leadership informed of key issues.
• Strong communication and coordination skills across functions and external partners.
• Comfortable handling production data, SOPs, and documentation.
• Proficient in Microsoft Office (Excel, PowerPoint); experience with ERP systems like SAP or Oracle is a plus.

Preferred Qualifications

• Experience in radiopharmaceutical or radiotracer production environments.
• Familiarity with lean manufacturing principles or continuous improvement tools.
• Exposure to quality systems or regulatory audits is a plus.

For U.S. based positions only, the pay range for this position is $105,600.00‑$158,400.00 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.

GE HealthCare offers a competitive benefits package, including 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 is an Equal Opportunity Employer. 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).