External Manufacturing Leader

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

📋 Description

• Act as the primary contact and liaison between GE HealthCare and external manufacturing partners involved in radiotracer production.

• Build and sustain relationships with external manufacturing sites.

• Conduct regular business reviews and align the performance of external manufacturers with corporate objectives.

• Ensure that external manufacturing operations comply with safety, EHS, 21 CFR 212, FDA, Board of Pharmacy, and other relevant regulations.

• Oversee quality assurance processes to ensure compliant and high-quality radiotracer production.

• Guarantee timely and accurate delivery while addressing production delays or capacity challenges.

• Resolve deviations, implement corrective and preventive measures, and enhance quality control processes.

• Streamline manufacturing processes for speed-to-market and cost efficiency.

• Drive initiatives aimed at cost savings while maintaining quality and compliance.

• Manage external manufacturing expenses, including negotiating pricing and terms with vendors.

• Identify and mitigate risks related to production, regulatory compliance, and supply chain.

• Develop contingency plans to address disruptions in radiotracer production and regulatory changes.

• Collaborate with Supply Chain, Operations, Regulatory Affairs, and R&D teams.

• Provide senior management with updates regarding external manufacturer performance, issues, risks, and solutions.

• Define, monitor, and report key performance indicators (KPIs) for external manufacturing performance.

• Monitor external partner performance to drive enhancements in quality, safety, cost, speed, and compliance.

⛳️ Requirements

• A Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field is required.

• An advanced degree such as an MBA or Master’s in Supply Chain is preferred.

• More than 8 years of experience in external manufacturing or operations management within regulated industries such as pharmaceuticals, biotechnology, or radiopharmaceuticals.

• A proven history of managing relationships with multiple external manufacturing sites, including contract manufacturing organizations (CMOs).

• Experience in quality management, compliance, and continuous improvement within regulated manufacturing operations.

• Demonstrated success in optimizing production processes for speed and cost while adhering to regulatory standards.

• In-depth knowledge of radiotracers, radiopharmacies, and 21 CFR 212 regulations is desirable.

• Familiarity with 21 CFR 212, FDA regulations, and GMP as they relate to radiopharmaceuticals and external manufacturing.

• Understanding of radiopharmacy operations, Board of Pharmacy requirements, and the handling of radiotracers.

• Strong leadership, interpersonal, and communication abilities.

• Proficient in problem-solving, negotiation, and conflict resolution.

• Capability to analyze complex data and implement process enhancements.

• Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.

• Ability to manage multiple projects and prioritize tasks effectively.

• Strong knowledge of SAP, Oracle, or other ERP systems is advantageous.

• Experience managing global manufacturing operations, particularly in radiotracer production.

• Previous experience in a radiopharmaceutical company or similar regulated manufacturing setting.

• Certification in quality management or project management is a plus.

• Must be legally authorized to work in the United States.

• GE HealthCare will not provide sponsorship for employment visas for this position.

• Successful completion of a drug screening may be required.

🏝️ Benefits

• 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.

• Competitive compensation.

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