External Manufacturing Manager

Job Description Summary
We are seeking a highly skilled and experienced External Manufacturing manager to oversee and manage relationships with external manufacturing partners across various sites, specifically those involved in the production of radiotracers. The ideal candidate will have a deep understanding of regulatory frameworks, including 21 CFR 212, and familiarity with radiopharmaceuticals, radiopharmacies, and Board of Pharmacy requirements. This role will focus on ensuring safety, quality, compliance, delivery, speed, and cost across these manufacturing sites while managing the complexities of radiotracer production.

Job Description

Key Responsibilities:

• Relationship Management:
  • Serve as the primary point of contact and key liaison between the company and external manufacturing partners, particularly those involved in radiotracer production.
  • Cultivate and maintain strong, effective relationships with external manufacturing sites to ensure consistent, high-quality production and compliance.
  • Lead and participate in regular business reviews, aligning the external manufacturers' performance with corporate goals, and addressing any issues proactively.
• Safety & Compliance:
  • Ensure all external manufacturing operations adhere to safety regulations, particularly in the production of radiotracers, and comply with environmental, health, and safety (EHS) guidelines.
  • Monitor and enforce compliance with 21 CFR 212 (for the production of radiopharmaceuticals), FDA regulations, and other relevant guidelines, ensuring all manufactured radiotracers meet stringent regulatory standards.
  • Oversee adherence to the Board of Pharmacy regulations, particularly with respect to radiopharmacies and the handling of radiopharmaceuticals.
• Quality & Delivery Assurance:
  • Manage the quality assurance processes to ensure the consistent production of high-quality radiotracers in compliance with GMP, FDA, and other regulatory requirements.
  • Ensure timely and accurate delivery of radiotracers, working with external manufacturers to address any issues related to production delays or capacity.
  • Collaborate with the quality assurance team to resolve deviations, implement corrective and preventive actions, and continuously improve quality control processes.
• Speed & Cost Management:
  • Optimize manufacturing processes to balance speed-to-market needs with cost-effectiveness, particularly for the production of radiopharmaceutical products.
  • Work closely with external manufacturers to drive cost-saving initiatives while maintaining high quality and compliance standards.
  • Ensure that external manufacturing costs are managed effectively, including negotiating pricing and terms with vendors to align with the company's financial objectives.
• Risk Management:
  • Proactively identify and mitigate risks related to external manufacturing operations, including production, regulatory compliance, and supply chain risks, especially with radiotracers.
  • Develop and implement contingency plans to address potential disruptions in radiotracer production, supply chain issues, or regulatory changes.
• Cross-functional Collaboration:
  • Collaborate with internal teams, including Supply Chain, Operations, Regulatory Affairs, and R&D, to ensure alignment and smooth operations across external manufacturing activities.
  • Provide leadership and regular updates to senior management on the performance of external manufacturers, focusing on key issues, risks, and solutions.
• Performance Metrics:
  • Define, monitor, and report on key performance indicators (KPIs) for external manufacturing performance, ensuring alignment with business goals for radiotracer production.
  • Track and report on the performance of external partners to drive continuous improvement in quality, safety, cost, speed, and compliance.

Qualifications:

• Education:
  • Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or related field; advanced degree (e.g., MBA, Master's in Supply Chain, or similar) preferred.
• Experience:
  • 8+ years of experience in external manufacturing or operations management within regulated industries such as pharmaceuticals, biotechnology, or radiopharmaceuticals.
  • In-depth experience with radiotracers, radiopharmacies, and 21 CFR 212 regulations, including handling and production of radiopharmaceuticals.
  • Proven track record in managing relationships with multiple external manufacturing sites, including contract manufacturing organizations (CMOs) specializing in radiotracer production.
  • Solid experience in quality management, compliance, and driving continuous improvements in manufacturing operations, particularly in regulated environments.
  • Demonstrated success in optimizing production processes for speed and cost while maintaining high regulatory standards.
• Skills & Competencies:
  • Extensive knowledge of 21 CFR 212, FDA regulations, and GMP as they apply to radiopharmaceuticals and external manufacturing.
  • Strong understanding of radiopharmacy operations, Board of Pharmacy requirements, and the handling of radiotracers in accordance with industry standards.
  • Strong leadership, interpersonal, and communication skills to effectively manage cross-functional teams and external partners.
  • Excellent problem-solving, negotiation, and conflict resolution skills.
  • Ability to analyze complex data, identify areas for process improvement, and implement actionable solutions.
  • Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
  • Proven ability to manage multiple projects simultaneously and prioritize tasks effectively.
  • Strong knowledge of SAP, Oracle, or other ERP systems is a plus.

Preferred Qualifications:

• Experience in managing global manufacturing operations, particularly in the production of radiotracers.
• Prior experience working in a radiopharmaceutical company or a similar regulated manufacturing environment.
• Certification in quality management or project management is a plus.

For U.S. based positions only, the pay range for this position is $148,720.00-$223,080.00 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.

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.

Relocation Assistance Provided: Yes