Site Quality Lead — GMP & Compliance Expert

Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma; Carlsbad (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies is seeking a Site Quality Lead in California to ensure FDA, cGMP, and internal quality standards are met across operations. You will oversee quality systems, support sterile manufacturing, and partner with operations, QC, and corporate quality teams to safeguard patient safety.

The role requires 3+ years in pharmaceutical QA/quality compliance, with strong knowledge of FDA regulations, GxP, and data integrity.

Qualifications

• Bachelor's degree in a scientific discipline.
• 3+ years in pharmaceutical QA or quality compliance, sterile or radiopharma preferred.
• Strong knowledge of FDA regulations, cGMP, and quality systems.
• Knowledge of GxP, FDA 21 CFR Part 11/211/212, USP <825>, and data integrity.
• Experience with electronic systems (LIMS, MES, ERP, CDS).
• Excellent communication, organization, and technical writing skills.
• Ability to work independently and manage multiple priorities.
• Collaborate with cross-functional stakeholders.

Responsibilities

• Maintain and improve quality systems (CAPA, deviation, change control, document control).
• Support audits including FDA inspections and customer audits.
• Ensure timely completion of quality events and CAPA implementation.
• Review batch records, QC data, and manufacturing documentation for accuracy.
• Provide training on GMP and compliance; write SOPs and reports.
• Collaborate with Production, QC, Regulatory, and Operations to ensure aseptic standards.
• Support regulatory submissions and responses to health authority inquiries.
• May serve as Radiation Safety Officer as needed.

Skills

Quality assurance

Regulatory compliance

Quality systems

Documentation

Auditing

Communication

Technical writing

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

Jubilant Radiopharmacies is seeking a Site Quality Lead in California to ensure FDA, cGMP, and internal quality standards are met across operations. You will oversee quality systems, support sterile manufacturing, and partner with operations, QC, and corporate quality teams to safeguard patient safety.

The role requires 3+ years in pharmaceutical QA/quality compliance, with strong knowledge of FDA regulations, GxP, and data integrity.