Pharma Site Quality Lead - GxP & Compliance

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

Benefits offered by this job

Annual performance bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies seeks a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP, and internal standards. You will oversee quality systems, support sterile operations, and partner with operations, QC, and corporate quality to improve processes impacting patient safety.

The role requires detail orientation and strong quality compliance knowledge, with potential to act as Radiation Safety Officer.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 3+ years in pharmaceutical quality assurance or quality compliance (sterile or radiopharmaceuticals) preferred.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Experience with 21 CFR parts and data integrity standards; audit support experience.

Responsibilities

• Maintain and improve quality systems (CAPA, change control, deviations, complaints, 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 compliance.
• Collaborate with Production and QC to ensure aseptic processing standards.

Skills

Quality mindset

Analytical thinking

Technical writing

Independent work

Cross-functional collaboration

Education

Bachelors in Chemistry, Biology, Pharmacy, or Engineering

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies seeks a Site Quality Lead to ensure radiopharmaceutical manufacturing meets FDA, cGMP, and internal standards. You will oversee quality systems, support sterile operations, and partner with operations, QC, and corporate quality to improve processes impacting patient safety.

The role requires detail orientation and strong quality compliance knowledge, with potential to act as Radiation Safety Officer.