Associate External Manufacturing Leader

MS0160 GE Healthcare Limited; United States; À distance; USD 106 000 - 158 000; Plein temps

Avantages offerts par ce poste

Tuition reimbursement

401(k) plan

Résumé du poste

GE HealthCare is seeking an Associate External Manufacturing Leader to provide tactical support across the radiotracer production network in the United States. You will monitor operations, ensure GMP compliance, and collaborate with internal teams and external CMOs to safeguard on-time delivery.

Ideal candidates have 3+ years in regulated manufacturing, familiarity with GMP and 21 CFR 212, and strong problem-solving, communication, and data-analytic skills, with experience using ERP systems like

Qualifications

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

Responsabilités

• 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 with Quality and Regulatory teams.
• Maintain batch records, change controls, and issue logs for assigned sites.
• Provide performance reports to the External Manufacturing Leader and senior leadership.

Connaissances

Detail-oriented

Independent work

Strong communication

Documentation

Microsoft Office

Formation

Bachelor’s degree in Life Sciences

Outils

SAP

Oracle

Description du poste

Job Description Summary

The Associate External Manufacturing Leader will provide tactical support across the radiotracer production network. Reporting to the External Manufacturing Leader (EML), this role involves executing and monitoring daily operations across the External Manufacturing network as assigned by the EML, ensuring compliance, quality, and on-time delivery from external manufacturing partners, while contributing to the strategic goals and initiatives of the External Manufacturing Organization. This role requires strong organizational skills, comfort working with regulated processes, and a collaborative mindset to support external sites and internal cross‑functional teams. Ideal candidates will have experience in pharmaceutical or radiopharmaceutical manufacturing and working knowledge of relevant regulations (e.g., 21 CFR 212, GMP).

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.

Partner and Site Interface

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.

Compensation & Benefits

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. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long‑term incentives (LTI).

• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Relocation Assistance

Provided: No

Other Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. 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). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.