Site Quality Lead, FDA/cGMP & Audits

Jubilant Pharma, LLC; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual performance bonus

Generous vacation and 401K matching

Job summary

Jubilant Radiopharmacies is seeking a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP, and internal quality standards. You will oversee quality systems, support sterile operations, and partner with operations, QC, and corporate quality teams.

This role is ideal for someone detail-oriented with strong quality compliance knowledge and a drive to improve processes impacting patient safety.

Qualifications

• Bachelor’s degree in a scientific discipline; quality focus preferred.
• 3+ years of pharmaceutical quality assurance or quality compliance experience.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• GxP, FDA 21 CFR Part 11/211/212, USP <825>, and data integrity familiarity.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS.

Responsibilities

• Maintain and improve quality systems including CAPA, change control, deviations, and document control.
• Support audits including FDA inspections and customer audits.
• Ensure timely completion of quality events and corrective actions.
• Monitor compliance with 21 CFR Part 212 and USP chapters.
• Review batch records, QC data, and manufacturing documentation for accuracy.

Skills

Quality assurance

Regulatory knowledge

Quality systems

Technical writing

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies is seeking a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP, and internal quality standards. You will oversee quality systems, support sterile operations, and partner with operations, QC, and corporate quality teams.

This role is ideal for someone detail-oriented with strong quality compliance knowledge and a drive to improve processes impacting patient safety.