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.

Essential Requirements:

• Bachelor’s degree required, advanced degree in a scientific discipline (Pharmacy, Chemistry, Chemical Engineering, Radio pharmacy, Nuclear Medicine, or related field) preferred.
• 12+ years of progressive Quality/GxP experience in pharmaceuticals or biologics, including 6+ years in radiopharmaceuticals or sterile/aseptic operations; RLT experience strongly preferred.
• Must have a working knowledge of FDA/EMA/ICH regulatory requirements
• Must have a broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
• Approximately 25% travel required.

Desirable Requirements:

• Prior accountability for batch release/Responsible Person or Qualified Person interface in EU or equivalent markets.
• Implementation of digital QMS, eQMS, and analytics-driven quality dashboards.
• Experience with novel radioisotopes (e.g., Lu-177, Ac-225) and associated supply chain constraints.
• Vendor/CMO oversight for radiolabeling, sterile fill-finish, and last-mile distribution.
• Post-approval change management and lifecycle management for radiopharmaceuticals.

The salary for this position is expected to range between $168,000 and $ 312,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here: novartis-life-handbook.pdf.