Quality Operations Lead
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Job Description
Lead quality operations at Novartis for US radioligand therapy manufacturing. Oversee compliance and champion best practices across sites with focus on patient safety and product excellence.
Responsibilities:
- 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, life and disability benefits
- a 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
- performance-based cash incentive
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