Radiopharma Site Quality Lead – Compliance & CAPA Champion

Jubilant Radiopharma; Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies in Chicago seeks a Site Quality Lead to ensure FDA, cGMP and internal quality standards across manufacturing operations.

You will oversee quality systems, support sterile manufacturing, and collaborate with Operations, QC and corporate quality to drive compliant, patient‑safety focused improvements.

Ideal candidates are detail oriented, with strong knowledge of QA compliance, and able to write investigations and training materials.

Qualifications

• 3+ years of experience in pharmaceutical quality assurance or quality compliance, preferably in sterile or radiopharmaceutical manufacturing.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• In‑depth understanding of GxP regulations, FDA 21 CFR Part 11, 21 CFR Part 211, 21 CFR Part 212, USP <825>, and global data integrity standards.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS.

Responsibilities

• Maintain and improve quality systems, including CAPA, change control, deviations, complaints, and document control.
• Support internal and external audits, including FDA inspections and customer audits.
• Ensure timely completion of quality events and implementation of effective corrective actions.
• Monitor compliance with 21 CFR Part 212 and applicable USP chapters.
• 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 teams to ensure aseptic processing standards are met.
• Support root cause analysis and write investigation reports for quality events.
• 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

Analytical thinking

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies in Chicago seeks a Site Quality Lead to ensure FDA, cGMP and internal quality standards across manufacturing operations.

You will oversee quality systems, support sterile manufacturing, and collaborate with Operations, QC and corporate quality to drive compliant, patient‑safety focused improvements.

Ideal candidates are detail oriented, with strong knowledge of QA compliance, and able to write investigations and training materials.