QC Manager

Novartis•Carlsbad, NM

1d•Onsite

About The Position

Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology Primary responsibilities for this position include performing tasks associated with in-coming material, in-process and release testing and reviewing laboratory data, coordinating the team/lab under its responsibility. Communicating with internal and external partners for the Quality Control organization. Supports site as technical expert in related field. This role will support manufacturing operations which will require shift work and scheduling which will require weekend work. Location: Carlsbad #CA-Onsite This role is located on-site in Carlsbad, CA. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you.

Requirements

Analytical Validation
Corrective and Preventive Action (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
Laboratory Excellence
SOP (Standard Operation Procedure) Management
KPI Reporting
Laboratory Excellence
Bachelor's degree in Chemistry, Biology, or other relevant scientific discipline
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 cGMP 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

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.
Coordination of departmental Operational activities
Initiate and drive local hiring process.
Lead OpEx Projects.
Investigation of Deviation, OOx, Complaints.
Define and implement CAPAs.
Support transfer Projects and validation studies.
Track team metrics and ensure KQI /KPI meet requirements.
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.