Site Quality Lead: Sterile Radiopharma, FDA/compliance

Jubilant Radiopharma; Chicago (IL); Vor Ort; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Generous vacation

401(k) matching

Zusammenfassung

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

The role fits detail-oriented professionals with quality compliance expertise who drive process improvements that impact patient safety. Competitive compensation and bonus opportunities are offered.

Qualifikationen

• Bachelor’s degree in a scientific discipline.
• 3+ years of experience in pharmaceutical quality assurance or quality compliance.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS.
• Ability to collaborate with cross-functional stakeholders.

Aufgaben

• Maintain and improve quality systems including CAPA, change control, deviations, complaints, and document control.
• Support audits, including FDA inspections and customer audits.
• Ensure timely completion of quality events and corrective actions.
• Review batch records, QC data, and manufacturing documentation for accuracy.
• 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.
• 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.

Kenntnisse

Communication skills

Analytical thinking

Technical writing

Organization

Collaboration

Independent work

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Jobbeschreibung

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

The role fits detail-oriented professionals with quality compliance expertise who drive process improvements that impact patient safety. Competitive compensation and bonus opportunities are offered.