Associate External Manufacturing Leader

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver tactical support throughout the radiotracer production network.

• Oversee and manage daily operations within the External Manufacturing network.

• Ensure compliance, quality standards, and timely delivery from external manufacturing partners.

• Work alongside site managers and manufacturing leadership to address operational challenges and implement necessary corrective actions.

• Monitor production activities, documentation, and radiotracer shipments to ensure accurate and timely delivery.

• Aid in root cause investigations for operational deviations in collaboration with Quality and Regulatory teams.

• Maintain batch records, change controls, and issue logs for designated manufacturing sites.

• Provide consistent performance reports to the External Manufacturing Leader and senior management.

• Assist in business reviews with external partners.

• Relay notifications of failures or delays to internal stakeholders and customers.

• Supervise site-level GMP and 21 CFR 212 compliance.

• Conduct readiness evaluations for new manufacturing locations, inspections, audits, and partner assessments.

• Support customer go-live supply planning and operational supply strategies.

• Help track CAPAs, deviations, and updates to SOPs.

• Act as a liaison between manufacturing partners and internal teams.

• Attend and document discussions or check-ins with CMOs or manufacturing partners.

• Escalate issues and risks along with suggested mitigation strategies.

• Monitor vendor performance metrics and assist in data collection and reporting.

• Incorporate AI tools and Power BI dashboards to enhance real-time visibility in manufacturing processes.

• Aid in the onboarding process of new regional manufacturing partners, including documentation and logistics setup.

• Ensure continuity of supply across CMO partners during failures.

• Identify opportunities for operational improvements and propose solutions for increased efficiency.

• Document and implement SOPs and best practices.

• Engage in Lean or Six Sigma initiatives.

• Contribute to the development of long-term manufacturing capability strategies and expansion plans.

⛳️ Requirements

• Preferred bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field; equivalent experience will be considered.

• At least 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment.

• Experience in pharmaceuticals, biotech, or radiopharmaceuticals is preferred.

• Familiarity with GMP, 21 CFR 212, and/or Board of Pharmacy regulations.

• Experience supporting or working in a multi-site manufacturing network is a plus.

• Excellent organizational, detail-oriented, and follow-up skills.

• Ability to work independently while keeping leadership informed of critical issues.

• Strong communication and coordination capabilities across functions and with external partners.

• Comfortable handling production data, SOPs, and documentation.

• Proficient in Microsoft Office, particularly Excel and PowerPoint.

• Experience with ERP systems like SAP or Oracle is advantageous.

• Prior experience in radiopharmaceutical or radiotracer production environments is preferred.

• Familiarity with lean manufacturing principles or continuous improvement methodologies.

• 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, either now or in the future.

🏝️ Benefits

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).

• Comprehensive medical, dental, and vision insurance.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• Relocation assistance is not provided.