RLT Quality Operations Lead - US (Remote)

Rlt Quality Operations Lead Us

At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world. The RLT Quality Operations Lead US, is a senior leadership role accountable for the end-to-end quality operations across all US RLT manufacturing facilities. This position sets the operational model for US quality operations, ensures compliance to international cGMP standards, Novartis rules and applicable market regulatory requirements, drives inspection readiness and success, and develops high-performing quality teams. The role oversees up to five US locations supporting both domestic and multiple ex-US markets. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and / or international) will be defined by the hiring manager. This position will require 25% travel.

Key Responsibilities :

• Provide strategic leadership and governance for Quality Operations across all US RLT manufacturing sites, ensuring consistent standards, processes, and performance.
• Ensure compliance with applicable regulations and standards (e.g., FDA, cGMP, ICH, Health Authority expectations) and alignment with global Quality policies and procedures.
• Lead inspection readiness and the execution of health authority, customer, and internal inspections; drive robust CAPA, remediation, and continuous improvement.
• Oversee site-level Quality functions (e.g., QA Operations, QC Laboratories, Batch Release, Deviation / Investigation Management, Change Control, Supplier Quality, Validation, Documentation Control).
• Partner with Manufacturing, Supply Chain, MS&T, Regulatory Affairs, EHS, and Global Quality to enable reliable, compliant supply to US and ex-US markets.
• Ensure robust product quality oversight for RLT products, including radiopharmaceutical-specific controls, aseptic and sterile manufacturing practices, and distribution considerations. Champion safety, ethical compliance, and patient-centric decision making in all quality activities.
• Drive harmonization of quality systems and digital tools across sites; sponsor standardization, data integrity, and lifecycle management initiatives. Foster networking and best practice sharing between the sites and regions.
• Lead talent strategy for US Quality Operations : workforce planning, capability building, succession, mentoring, and culture of ownership and continuous improvement.
• Own risk management for US sites : conduct quality risk assessments, implement mitigation plans, and ensure escalation / communication to senior leadership. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Manage budgets and resources for Quality Operations; optimize spend while safeguarding compliance and product quality.

Essential Requirements :