Associate External Manufacturing Leader

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $105.6k - $158.4k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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Logo of GE HealthCare

GE HealthCare

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Provide tactical support across the radiotracer production network • Execute and monitor daily operations across the External Manufacturing network • Ensure compliance, quality, and on-time delivery from external manufacturing partners • Collaborate with site managers and manufacturing leadership to resolve operational challenges and implement corrective actions • Track production activities, documentation, and radiotracer shipments for accurate and timely delivery • Support root cause investigations for operational deviations with Quality and Regulatory teams • Maintain batch records, change controls, and issue logs for assigned manufacturing sites • Provide regular performance reports to the External Manufacturing Leader and senior leadership • Support business reviews with external partners • Communicate failure or delay notifications to internal stakeholders and customers • Monitor site-level GMP and 21 CFR 212 compliance • Conduct readiness reviews for new manufacturing locations, inspections, audits, and partner reviews • Support customer go-live supply planning and operational supply plans • Assist with tracking CAPAs, deviations, and SOP updates • Serve as liaison between manufacturing partners and internal teams • Attend and document calls or check-ins with CMOs or manufacturing partners • Escalate issues and risks with suggested mitigation steps • Track vendor performance metrics and support data collection and reporting • Integrate AI tools and Power BI dashboards to improve real-time manufacturing visibility • Assist with onboarding new regional manufacturing partners, including documentation and logistics setup • Facilitate continuity of supply across CMO partners when failures occur • Identify operational improvements and propose efficiency solutions • Document and implement SOPs and best practices • Participate in Lean or Six Sigma initiatives • Assist in developing long-term manufacturing capability strategies and expansion plans

🎯 Requirements

• Bachelor’s degree preferred in Life Sciences, Chemistry, Engineering, or related field; equivalent experience considered • Minimum of 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment • Experience in pharmaceuticals, biotech, or 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 • Strong organizational, detail-oriented, 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 • Proficient in Microsoft Office, including Excel and PowerPoint • Experience with ERP systems such as SAP or Oracle is a plus • Experience in radiopharmaceutical or radiotracer production environments preferred • Familiarity with lean manufacturing principles or continuous improvement tools • Exposure to quality systems or regulatory audits is a plus • Must be legally authorized to work in the United States • GE HealthCare will not sponsor employment visas, now or in the future

🏖️ Benefits

• Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI) • Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Relocation assistance not provided

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