Site Quality Lead - GMP Compliance & QA for Radiopharma

Jubilant Radiopharma; San Diego (CA); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Generous vacation

401K matching

Descripción de la vacante

Jubilant Radiopharmacies in California is seeking a Site Quality Lead to help ensure radiopharmaceutical manufacturing operations meet FDA, cGMP and internal quality standards. You will oversee quality systems, support sterile manufacturing, and partner with operations, QC and corporate quality.

This role is ideal for detail-oriented professionals with quality compliance knowledge and a drive to improve processes that affect patient safety.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Effective communication

Organizational skills

Analytical thinking

Technical writing

Independent work

Cross-functional collaboration

Educación

Bachelor's degree in Science

Herramientas

LIMS

MES

ERP

CDS

Descripción del empleo

Jubilant Radiopharmacies in California is seeking a Site Quality Lead to help ensure radiopharmaceutical manufacturing operations meet FDA, cGMP and internal quality standards. You will oversee quality systems, support sterile manufacturing, and partner with operations, QC and corporate quality.

This role is ideal for detail-oriented professionals with quality compliance knowledge and a drive to improve processes that affect patient safety.