Novartis

Compensation

Full Description

Job Description: • Provide strategic leadership for quality operations across US radioligand therapy manufacturing sites. • Define and implement the operating model for US quality operations, including organization design and performance management. • Ensure compliance with current Good Manufacturing Practice (cGMP) standards and global Novartis quality policies. • 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. • Lead inspection readiness and successful execution of health authority, customer, and internal inspections. • 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 international markets. • Drive harmonization of quality systems and digital tools across sites, promoting data integrity and lifecycle management. Requirements: • Bachelor’s degree in a scientific discipline required; advanced degree preferred. • Minimum 10 years of progressive quality experience in pharmaceuticals or biologics, with at least 7 years in radiopharmaceuticals or sterile/aseptic operations. • Previous experience as a Site Quality Head. • Working knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization (ICH) regulatory requirements. • Proven track record of successful regulatory inspections, corrective and preventive action (CAPA) management, and quality system deployment. • Strong people leadership skills, including team building, talent development, and stakeholder management. Benefits: • health insurance • life and disability benefits • 401(k) with company contribution and match • generous time off package including vacation, personal days, holidays and other leaves