External Manufacturing Leader

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $140k - $210k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GE HealthCare

WebsiteLinkedInAll Job Openings

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

• Serve as the primary point of contact and liaison between GE HealthCare and external manufacturing partners involved in radiotracer production • Cultivate and maintain relationships with external manufacturing sites • Lead regular business reviews and align external manufacturer performance with corporate goals • Ensure external manufacturing operations follow safety, EHS, 21 CFR 212, FDA, Board of Pharmacy, and other applicable requirements • Manage quality assurance processes for compliant, high-quality radiotracer production • Ensure timely and accurate delivery and address production delays or capacity issues • Resolve deviations, implement corrective and preventive actions, and improve quality control processes • Optimize manufacturing processes for speed-to-market and cost-effectiveness • Drive cost-saving initiatives while maintaining quality and compliance • Manage external manufacturing costs, including negotiating vendor pricing and terms • Identify and mitigate production, regulatory compliance, and supply chain risks • Develop contingency plans for radiotracer production disruptions and regulatory changes • Collaborate with Supply Chain, Operations, Regulatory Affairs, and R&D teams • Provide senior management with updates on external manufacturer performance, issues, risks, and solutions • Define, monitor, and report KPIs for external manufacturing performance • Track external partner performance to drive improvements in quality, safety, cost, speed, and compliance

🎯 Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or related field required • Advanced degree such as an MBA or Master’s in Supply Chain preferred • 8+ years of experience in external manufacturing or operations management within regulated industries such as pharmaceuticals, biotechnology, or radiopharmaceuticals • Proven track record managing relationships with multiple external manufacturing sites, including contract manufacturing organizations (CMOs) • Experience in quality management, compliance, and continuous improvement in regulated manufacturing operations • Success optimizing production processes for speed and cost while maintaining regulatory standards • In-depth experience with radiotracers, radiopharmacies, and 21 CFR 212 regulations desired • Knowledge of 21 CFR 212, FDA regulations, and GMP as applied to radiopharmaceuticals and external manufacturing • Understanding of radiopharmacy operations, Board of Pharmacy requirements, and handling radiotracers • Strong leadership, interpersonal, and communication skills • Problem-solving, negotiation, and conflict resolution skills • Ability to analyze complex data and implement process improvements • Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies • Ability to manage multiple projects and prioritize tasks • Strong knowledge of SAP, Oracle, or other ERP systems is a plus • Experience managing global manufacturing operations, particularly radiotracer production • Prior experience in a radiopharmaceutical company or similar regulated manufacturing environment • Certification in quality management or project management is a plus • Must be legally authorized to work in the United States • GE HealthCare will not sponsor employment visas for this opening • Successful completion of a drug screen, as applicable

🏖️ Benefits

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