QC Manager

Role Summary

Help reimagine cancer care by shaping how Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. This role performs tasks related to in-coming material, in-process and release testing and reviews laboratory data, and coordinates the QC team and lab activities. You will communicate with internal and external partners for the Quality Control organization and serve as the technical expert in the field. The role will support manufacturing operations requiring shift work and weekend scheduling. Location: Carlsbad, CA (onsite).

Responsibilities

• Management of QC Analytical activities in line with site objectives. Coordination of departmental Operational activities. Track team metrics and ensure KQI /KPI meet requirements.
• Initiate and drive local hiring process.
• Lead OpEx Projects.
• Investigation of Deviation, OOx, Complaints.
• Define and implement CAPAs.
• Support transfer Projects and validation studies.
• HSE incidents reporting and action follow up.
• New equipment commissioning Support (OQ, PQ).
• Resource and capacity (people and equipment) planning and workload management.
• Performance and leadership support of QC Analytical team.
• Ensure availability of equipment, chemicals and consumables, as appropriate.
• SOP review and revision.
• Ensure training according to cGxP requirements.
• Management of documentation and methods according to cGxP.
• Exception management.
• Ensure DI and compliance with cGxP and all regulatory requirements.
• Leadership in GxP audits and fulfillment of internal/external audit and inspection plans.
• Equipment qualification review /release.
• Ensure Methods and Procedures are up to date.
• Ensure qualification /calibration status of analytical equipment.
• Microbiological testing review and approval.

Qualifications

• Minimum of 5 years of work experience in Quality Control of pharmaceutical products, preferably radiopharmaceuticals
• 2 years of experience in a people manager role
• Experience in managing a cGxP laboratory
• Knowledge of following analytical methods/equipment: HPLC, iTLC, Endotoxin, Bioburden, pH, NVP and viable particle counters
• Knowledge of FDA regulations regarding the manufacturing of radiopharmaceuticals
• Applied knowledge of GXP and EP/USP guidelines

Skills

• Analytical Validation
• CAPA Knowledge
• Deviation Management
• Equipment Calibration Management
• Equipment Qualification Management
• Good Manufacturing Practices (cGMP)
• Audit & Inspection Management
• Quality Control
• Quality Management Systems
• Quality Control Microbiology
• Stability Management
• SOP Management
• KPI Reporting

Education

• Bachelor's degree in Chemistry, Biology, or other relevant scientific discipline