Site Quality Leader – GMP, 21 CFR, Quality Improvement

Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma; Orlando (FL); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual performance bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies in Orlando seeks a Site Quality Lead to ensure our radiopharmaceutical manufacturing meets FDA, cGMP, and internal standards.

You will oversee quality systems, review batch records, support audits, and collaborate with operations, QC, and engineering to drive compliance and continuous improvement. This role emphasizes patient safety and process excellence in a hands-on, cross-functional environment.

Qualifications

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
• 3+ years in pharmaceutical quality assurance or quality compliance, preferably sterile or radiopharmaceutical manufacturing.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS.
• Excellent written and verbal communication and strong documentation skills.

Responsibilities

• Maintain and improve quality systems (CAPA, change control, deviations, complaints, docs).
• Support audits, including FDA inspections and customer audits.
• Review batch records and manufacturing documentation for compliance.
• Monitor 21 CFR Part 212 and USP chapters alignment.
• Collaborate with Production, QC and regulatory teams.
• Prepare investigation reports and root cause analyses.

Skills

Regulatory knowledge

Quality systems

Technical writing

Cross-functional collaboration

Analytical thinking

Independent work

Prioritization

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies in Orlando seeks a Site Quality Lead to ensure our radiopharmaceutical manufacturing meets FDA, cGMP, and internal standards.

You will oversee quality systems, review batch records, support audits, and collaborate with operations, QC, and engineering to drive compliance and continuous improvement. This role emphasizes patient safety and process excellence in a hands-on, cross-functional environment.