Site Quality Lead - GMP & QA for Radiopharmaceuticals

Jubilant Pharma, LLC; Chicago (IL); Vor Ort; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Generous vacation

401K matching

Zusammenfassung

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 to drive patient safety.

The role emphasizes meticulous process improvement, documentation, and regulatory submissions while coordinating with Production and QA to maintain aseptic processing and data integrity compliance.

Qualifikationen

• Bachelor’s degree in a scientific discipline or related field.
• 3+ years in pharmaceutical quality assurance or quality compliance, preferably sterile/radiopharmaceutical.
• Strong knowledge of FDA regulations, cGMP, and quality systems.

Aufgaben

• Maintain and improve quality systems (CAPA, change control, deviations, complaints, document control).
• Support internal and external 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 standards.
• Review batch records and manufacturing documentation for accuracy.

Kenntnisse

Regulatory knowledge

Quality systems

Analytical thinking

Technical writing

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Jobbeschreibung

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 to drive patient safety.

The role emphasizes meticulous process improvement, documentation, and regulatory submissions while coordinating with Production and QA to maintain aseptic processing and data integrity compliance.