Site Quality Lead - Radiopharma Quality & Compliance

Jubilant Pharma Limited; Orlando (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual performance bonus

401K matching

Competitive compensation

Job summary

Jubilant Radiopharmacies is seeking a Site Quality Lead to oversee quality systems and ensure our radiopharmaceutical manufacturing operations meet FDA, cGMP, and internal quality standards. You will partner with operations, QC, and corporate quality teams to drive corrective actions and process improvements that impact patient safety.

The role suits someone detail-oriented with quality compliance expertise, capable of supporting sterile manufacturing and audits, and leading GMP training and SOP

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 parts 11/211/212, USP, and data integrity standards.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS; strong communication and technical writing skills.

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.
• Write investigation reports and support root cause analysis.

Skills

Quality assurance

FDA regulations

cGMP

GxP

Documentation

Quality systems

Analytical thinking

Technical writing

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies is seeking a Site Quality Lead to oversee quality systems and ensure our radiopharmaceutical manufacturing operations meet FDA, cGMP, and internal quality standards. You will partner with operations, QC, and corporate quality teams to drive corrective actions and process improvements that impact patient safety.

The role suits someone detail-oriented with quality compliance expertise, capable of supporting sterile manufacturing and audits, and leading GMP training and SOP