Site Quality Lead – Radiopharmaceutical Manufacturing

Jubilant Radiopharma; Orlando (FL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual performance bonus

Generous vacation

401K matching

Competitive compensation

Job summary

Jubilant Radiopharmacies in Orlando, FL, seeks a Site Quality Lead to oversee quality systems and ensure operations meet FDA, cGMP, and internal standards. You will partner with operations, QC, and corporate quality to safeguard patient safety and drive continuous improvement.

The role requires detail orientation, strong knowledge of regulatory requirements, and effective technical writing. Responsibilities include audits, CAPA, document control, batch record reviews, and training across teams.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
• 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 Part 11, 21 CFR Part 211, 21 CFR Part 212, USP <825>, and global data integrity standards.
• Experience with electronic systems such as LIMS, MES, ERP, or CDS.
• Strong communication, organization, analytical thinking, and technical writing skills.
• Ability to work independently and manage multiple priorities effectively.
• Ability to collaborate well with cross‑functional stakeholders.

Responsibilities

• Maintain and improve quality systems (CAPA, change control, deviations, complaints, and 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 accuracy and compliance.
• Support regulatory submissions and health authority inquiries.
• May serve as Radiation Safety Officer.
• Collaborate with Production and QC to meet aseptic processing standards.
• Write investigation reports and root cause analyses for quality events.
• Participate in environmental monitoring review and sterility assurance activities.
• Develop and deliver GMP/compliance training.
• Write and update SOPs, protocols, and reports.
• Identify and implement process improvements.
• Partner with Corporate Quality, Supply Chain, Radiation Safety, Engineering, Operations.

Skills

Quality systems

CAPA

Change control

Audits

FDA regulations

GxP

21 CFR Part 11

Data integrity

LIMS/MES/ERP/CDS

Regulatory submissions

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies in Orlando, FL, seeks a Site Quality Lead to oversee quality systems and ensure operations meet FDA, cGMP, and internal standards. You will partner with operations, QC, and corporate quality to safeguard patient safety and drive continuous improvement.

The role requires detail orientation, strong knowledge of regulatory requirements, and effective technical writing. Responsibilities include audits, CAPA, document control, batch record reviews, and training across teams.