Radiopharma Regulatory & Quality Lead

The General Hospital Corporation; Edwards (CO); On-site; USD 99,000 - 142,000; Full time

Job summary

The General Hospital Corporation is seeking a quality management professional to support PET radiopharmaceutical operations at the Edwards facility. The role focuses on cGMP documentation, staff education in quality tools, and leading improvements to the quality system while maintaining regulatory readiness.

The candidate will work onsite with a suite of duties including CAPA, change control, and collaboration with internal teams to ensure compliance and high-quality outputs in a lab environment

Qualifications

• 3–5 years of direct experience in a pharmaceutical manufacturing field.
• 2–3 years supervisory experience.
• Preferred: Certification in quality management or other cGMP certification.
• Bachelor’s degree required in a related field.

Responsibilities

• Authors and reviews SOPs, technical reports, and other cGMP documents.
• Educates staff on quality improvement methodologies and tools.
• Leads improvements to quality management system and ensures inspection readiness.
• Maintains regulatory compliance with FDA, Mass DPH, and other bodies.
• Manages CAPA, change control, and vendor complaint handling.

Skills

Quality improvement

Regulatory knowledge

Leadership

Education

Bachelor’s degree

Job description

The General Hospital Corporation is seeking a quality management professional to support PET radiopharmaceutical operations at the Edwards facility. The role focuses on cGMP documentation, staff education in quality tools, and leading improvements to the quality system while maintaining regulatory readiness.

The candidate will work onsite with a suite of duties including CAPA, change control, and collaboration with internal teams to ensure compliance and high-quality outputs in a lab environment