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Associate External Manufacturing Leader
GE HealthCare. Provide tactical support across the radiotracer production network .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing operations within a regulated manufacturing environment, ensuring compliance with GMP and 21 CFR 212 standards while effectively collaborating with external partners. Proficient in tracking production metrics and implementing continuous improvement initiatives to enhance operational efficiency.
Highest-signal resume keywords
GMP Compliance21 CFR 212 KnowledgeOperational Support in ManufacturingExperience with ERP SystemsStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Production Data ManagementSOP DocumentationQuality Systems ExposureRoot Cause InvestigationBatch Record MaintenanceChange Control ManagementCAPA TrackingLean Manufacturing PrinciplesSix Sigma MethodologiesRadiopharmaceutical Production
Soft Skills
Organizational SkillsDetail-OrientedIndependent WorkCoordination SkillsFollow-Up Skills
Tools & Technologies
Microsoft OfficeExcelPowerPointSAPOracleAI ToolsPower BI
Industry Keywords
PharmaceuticalsBiotechRadiopharmaceuticalsExternal ManufacturingMulti-Site Manufacturing NetworkRegulatory EnvironmentQuality AuditsOperational ChallengesPerformance ReportingVendor Performance Metrics
Tech Stack
Tools & technologiesERPOracle
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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