Site Quality Lead - Regulatory & QA Excellence

Jubilant Pharma, LLC; Orlando, Northern (FL, KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Jubilant Radiopharmacies is seeking a Site Quality Lead to oversee QA systems and support sterile manufacturing operations, partnering with Operations, QC and corporate quality to safeguard patient safety.

The ideal candidate has a scientific background, 3+ years in pharmaceutical quality, and strong knowledge of FDA regulations, cGMP and data integrity, with experience across LIMS/MES/ERP/CDS systems.

Qualifications

• Bachelor's degree in science, engineering or related field.
• 3+ years in pharmaceutical quality assurance or quality compliance.
• Strong knowledge of FDA regulations, cGMP and quality systems.
• Experience with data integrity and 21 CFR Part 11/211/212.
• Experience with LIMS, MES, ERP or CDS systems.

Responsibilities

• Maintain and improve quality systems including CAPA and change control.
• Support audits, FDA inspections and customer audits.
• Ensure timely completion of quality events and CAPA closures.
• Monitor compliance with 21 CFR Part 212 and USP chapters.
• Review batch records and manufacturing documentation for compliance.
• Collaborate with Production and QC to ensure aseptic standards.

Skills

Communication

Analytical thinking

Technical writing

Organizational skills

Independent work

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies is seeking a Site Quality Lead to oversee QA systems and support sterile manufacturing operations, partnering with Operations, QC and corporate quality to safeguard patient safety.

The ideal candidate has a scientific background, 3+ years in pharmaceutical quality, and strong knowledge of FDA regulations, cGMP and data integrity, with experience across LIMS/MES/ERP/CDS systems.