RLT Quality Operations Lead US (Remote)

Novartis • Indianapolis, IN

23h • Remote

About The Position

Are you ready to lead quality operations that directly impact patient safety and product excellence? As the RLT Quality Operations Lead for the US, you’ll shape the future of radioligand therapy manufacturing, championing best practices and driving innovation across multiple sites. Join a team where your expertise will empower high-performing colleagues and ensure our therapies reach those who need them most.

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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees