Site Quality Lead - Radiopharma & Compliance

Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma; Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Performance bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies in Chicago seeks a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP and internal standards. You will oversee quality systems, support sterile operations, and partner with operations, QC and corporate quality to safeguard patient safety.

This role emphasizes CAPA, change control, audits, and regulatory submissions. The ideal candidate is detail-oriented with strong writing and cross-functional collaboration skills, ready to drive process

Qualifications

• Bachelor's degree in a scientific discipline.
• 3+ years in pharmaceutical quality assurance or quality compliance.
• Experience in sterile or radiopharmaceutical manufacturing preferred.
• Strong knowledge of FDA regulations and cGMP.
• Familiar with FDA 21 CFR Part 11, 211, 212; USP <825> data integrity.
• Experience with LIMS, MES, ERP, or CDS systems.
• Excellent communication, organization, and technical writing.
• Ability to work independently and manage multiple priorities.
• Collaborates well with cross-functional stakeholders.

Responsibilities

• Maintain and improve quality systems including CAPA, change control, deviations, complaints, and document control.
• Support internal and external audits including FDA inspections.
• Ensure timely completion of quality events and corrective actions.
• Monitor 21 CFR Part 212 and USP chapters compliance.
• Review batch records, QC data and manufacturing documentation for accuracy and compliance.
• Perform batch trend tracking and upload batch information required by customers.
• Support regulatory submissions and responses to health authority inquiries.
• May serve as the Radiation Safety Officer.
• Collaborate with Production and QC to ensure aseptic processing standards.
• Support root cause analysis and write investigation reports.
• Participate in environmental monitoring review, trending, and sterility assurance activities, including media fill validations.
• Develop and deliver GMP and compliance training.
• Write and update SOPs, protocols, and reports in alignment with regulatory expectations.
• Identify and implement process improvements that enhance quality and operational efficiency.
• Partner with Corporate Quality, Supply Chain, Radiation Safety, Engineering, and Operations to support site readiness and compliance.

Skills

Quality assurance

Regulatory knowledge

GxP compliance

Documentation

Technical writing

Analytical thinking

Cross-functional collaboration

Independent worker

Education

Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering)

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies in Chicago seeks a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP and internal standards. You will oversee quality systems, support sterile operations, and partner with operations, QC and corporate quality to safeguard patient safety.

This role emphasizes CAPA, change control, audits, and regulatory submissions. The ideal candidate is detail-oriented with strong writing and cross-functional collaboration skills, ready to drive process