Site Quality Lead – GMP, FDA Compliance (Sterile)

Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual bonus

401K matching

Vacation

Job summary

Jubilant Radiopharmacies in Illinois seeks a Site Quality Lead to oversee quality systems, CAPA, change control, deviations, and documentation to meet FDA, cGMP, and internal standards, ensuring patient safety and regulatory readiness.

You will partner with Operations, QC, and Corporate Quality to drive process improvements, audits, environmental monitoring, and regulatory submissions, with potential Radiation Safety Officer duties.

Qualifications

• Bachelor's degree in a scientific discipline and relevant certifications.
• 3+ years in pharmaceutical quality assurance or quality compliance, preferably in sterile or radiopharmaceutical manufacturing.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Experience with GxP regulations (FDA 21 CFR Part 11/211/212) and data integrity standards.
• Experience with electronic systems (LIMS, MES, ERP, or CDS).
• Excellent communication, organization, analytical thinking, and technical writing skills.
• Ability to work independently and manage multiple priorities; collaborate cross-functionally.

Responsibilities

• Maintain and improve quality systems including CAPA, change control, deviations, and document control.
• Support internal and external audits, including FDA inspections and customer audits.
• Ensure timely completion of quality events and effective corrective actions.
• Monitor compliance with 21 CFR Part 212 and USP chapters.
• Review batch records and manufacturing documentation for accuracy and compliance.
• Support regulatory submissions and responses to health authority inquiries.
• May serve as Radiation Safety Officer.
• Collaborate with Production and QC to ensure aseptic processing standards.
• Develop and deliver GMP and compliance training.
• Write and update SOPs, protocols, and reports in line with regulatory expectations.
• Identify and implement process improvements that enhance quality and efficiency.

Skills

GxP knowledge

Quality systems

Regulatory knowledge

Documentation & writing

Cross-functional collaboration

Analytical thinking

Project management

Independent worker

Communications

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies in Illinois seeks a Site Quality Lead to oversee quality systems, CAPA, change control, deviations, and documentation to meet FDA, cGMP, and internal standards, ensuring patient safety and regulatory readiness.

You will partner with Operations, QC, and Corporate Quality to drive process improvements, audits, environmental monitoring, and regulatory submissions, with potential Radiation Safety Officer duties.