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 Global Head of Quality Compliance RLT is the enterprise leader responsible for designing, governing, and continuously improving the quality compliance strategy for radioligand therapies (RLT) across manufacturing, testing, release, distribution, and post-market surveillance. This role ensures global adherence to GxP requirements (GCP, GMP, GLP, GDP), nuclear/radiation safety regulations, and product-specific standards for radiopharmaceuticals across all regions.
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.
Job Description
Key Responsibilities:
* Define and own the global Quality Compliance strategy for RLT, aligning with corporate objectives and regulatory expectations across the product lifecycle. Manage and develop a high-performing global quality compliance team; establish clear roles, talent pipelines, and succession plans.
* Establish, maintain, and continuously improve the Quality Management System (QMS) for RLT, including procedures, policies, digital quality systems, data integrity controls, and metrics. Develop and monitor quality KPIs and management reviews, present compliance status to executive leadership and governance boards.
* Oversee global inspection readiness and support regulatory inspections and partner audits (e.g., FDA, EMA, MHRA, PMDA, Health Canada) for RLT operations. Budget ownership for the Quality Compliance function.
* Ensure compliance with regulations and standards applicable to radiopharmaceuticals, including GMP for aseptic processing, Annex 1, sterile fill-finish, API/Drug Substance controls, and Good Distribution Practices for time- and temperature-sensitive, radioactive products.
* Lead the global internal audit program for RLT sites, CMOs, CROs, and key suppliers; ensure robust risk-based qualification and ongoing oversight.
* Serve as executive Quality decision-maker for significant deviations, OOS/OOT, change controls, CAPA effectiveness, and batch disposition policies; ensure independent QA oversight.
* Own global quality risk management, including product quality risk assessments, radiation safety interface, and business continuity planning for short-shelf-life products.
* Partner with Manufacturing, Supply Chain, Technical Operations, R&D, Pharmacovigilance, EHS, and Regulatory Affairs to ensure integrated, compliant, and efficient operations. Sponsor quality culture initiatives, training, and capability-building, emphasizing right-first-time, safety, and patient focus.
* Drive data integrity by design and computerized system compliance (e.g., Annex 11, 21 CFR Part 11) across labs, manufacturing, and serialization/track-and-trace systems.
* Oversee complaint handling, field alert/biological product deviation reporting, recall readiness, and post-market commitments for RLT.
* Lead quality due diligence and integration for M&A, licensing, and external manufacturing networks specific to radiopharmaceuticals and radioisotope supply.