Site Quality Lead — GMP & Compliance

Jubilant Radiopharma; San Diego (CA); On-site; USD 120,000 - 170,000; 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 FDA, cGMP, and internal quality standards across radiopharmaceutical manufacturing. You’ll oversee quality systems, support sterile operations, and partner with operations, QC, and corporate teams to safeguard patient safety.

The role emphasizes CAPA, change control, deviations, and document control, with opportunities to drive improvements and train teams. Excellent detail orientation and written communication are essential.

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, 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.
• Perform batch trend tracking and upload batch information required by customers.
• Support regulatory submissions and responses to health authority inquiries.
• May serve as the Radiation Safety Officer.
• Collaborate with Production and QC teams to ensure aseptic processing standards are met.
• Support root cause analysis and write investigation reports for quality events.
• Participate in environmental monitoring review, trending, and sterility assurance activities, including media fill validations.
• Develop and deliver GMP and compliance training.
• Write and update SOPs, protocols, and reports in alignment with regulatory expectations.
• Identify and implement process improvements that enhance quality and operational efficiency.
• Partner with Corporate Quality, Supply Chain, Radiation Safety, Engineering, and Operations to support site readiness and compliance.

Skills

Quality mindset

Documentation & writing

Regulatory knowledge

Cross-functional collaboration

Independent work

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies seeks a Site Quality Lead to ensure FDA, cGMP, and internal quality standards across radiopharmaceutical manufacturing. You’ll oversee quality systems, support sterile operations, and partner with operations, QC, and corporate teams to safeguard patient safety.

The role emphasizes CAPA, change control, deviations, and document control, with opportunities to drive improvements and train teams. Excellent detail orientation and written communication are essential.