Senior Scientist, Laboratory QA
Immunovant
Global Head, Quality and Compliance
Novartis
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $168,000 - $312,000 per year
Job Level
Lead
About the role
- 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)
- 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
- 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
Requirements
- Bachelor’s degree required; advanced degree preferred (Pharmacy, Chemistry, Chemical Engineering, Radiopharmacy, Nuclear Medicine, or related field)
- 12+ years of progressive Quality/GxP experience in pharmaceuticals or biologics
- 6+ years experience in radiopharmaceuticals or sterile/aseptic operations; RLT experience strongly preferred
- Working knowledge of FDA/EMA/ICH regulatory requirements
- Broad cGMP experience with knowledge of manufacturing, quality control, and validation requirements and activities
- Knowledge of GMP for aseptic processing, Annex 1, sterile fill-finish, API/Drug Substance controls, and Good Distribution Practices for time- and temperature-sensitive, radioactive products
- Experience implementing digital QMS, eQMS, and analytics-driven quality dashboards (desirable)
- Knowledge of Annex 11 and 21 CFR Part 11 for computerized system compliance
- Experience with novel radioisotopes (e.g., Lu-177, Ac-225) and associated supply chain constraints (desirable)
- Vendor/CMO oversight experience for radiolabeling, sterile fill-finish, and last-mile distribution (desirable)
- Prior accountability for batch release/Responsible Person or Qualified Person interface in EU or equivalent markets (desirable)
- Experience with post-approval change management and lifecycle management for radiopharmaceuticals (desirable)
- Leadership and people management experience; ability to build talent pipelines and succession plans
- Budget ownership experience and ability to present compliance status to executive leadership
- Willingness/ability to travel approximately 25%
