Job Description Summary

Highly skilled and experienced External Quality Leader 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.

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Job Description

Key Responsibilities:

• Serve as the primary point of contact for Quality and key liaison between the company and external manufacturing partners,

• Cultivate and maintain strong, effective relationships with external manufacturing sites to ensure consistent, high-quality production and compliance.

• Participate in regular business reviews, aligning the external manufacturers’ performance with corporate goals, and addressing any issues proactively. Safety & Compliance

• 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.

• Ensure all external manufacturing operations adhere to quality regulations and requirements, 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.

• 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.

• Provide leadership and regular updates to senior management on the performance of external manufacturers, focusing on key issues, risks, and solutions.

• Collaborate with internal teams, including Supply Chain, Operations, Regulatory Affairs, and R&D, to ensure alignment and smooth operations across external manufacturing activities.

Qualifications:

• 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.

• Solid experience in quality management, compliance, and driving continuous improvements in manufacturing operations, particularly in regulated environments.

• 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.

• Demonstrated success in optimizing production processes for speed and cost while maintaining high regulatory standards.

• Ability to travel domestically up to 30%.

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