RLT Head QA Operations US

Novartis • Indianapolis, IN

6d • $168,000 - $312,000 • Onsite

About The Position

Imagine knowing that the quality decisions you make today directly protect patients tomorrow. In this senior leadership role, you’ll shape and lead end-to-end Quality Operations across our United States Radioligand Therapy manufacturing network—setting the operating model, building high-performing teams, and raising the bar for inspection readiness and compliance so life-changing cancer therapies can be delivered with confidence. You’ll partner closely with manufacturing, supply chain, regulatory, and global quality colleagues to strengthen a culture of ownership, integrity, and continuous improvement—helping Novartis reimagine medicine at scale while ensuring every product meets the highest standards.

Requirements

• Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Chemical Engineering, Radiopharmacy, Nuclear Medicine, or related field) is required; advanced scientific degree preferred
• At least twelve years of progressive quality experience in pharmaceutical or biologics manufacturing environments including 7+ years in radiopharmaceuticals or sterile/aseptic operations
• Working knowledge of FDA/EMA/ICH regulatory requirements.
• Proven track record of successful regulatory inspections (FDA and ex-US authorities), CAPA management, and quality system deployment.
• Strong people leadership and stakeholder management skills within complex, matrix organizations
• Experience with global supply networks supporting multiple markets and product lifecycle stages
• Approximately 25% travel required.

Nice To Haves

• Prior experience with site start-up or rapid site expansion
• Experience or formal training in radioligand therapies, radiopharmaceuticals, or radiation safety

Responsibilities

• Lead end-to-end Quality Operations across United States Radioligand Therapy manufacturing sites, ensuring consistent standards and performance
• Define and implement the United States Quality Operations operating model, including organization design, governance, and escalation pathways
• Ensure compliance with regulatory requirements, current Good Manufacturing Practice standards, and Novartis Quality policies
• Drive inspection readiness and lead successful health authority, customer, and internal inspections; drive robust CAPA, remediation, and continuous improvement.
• Provide quality oversight for radiopharmaceutical manufacturing, including sterile and aseptic manufacturing practices, and distribution considerations
• Partner cross-functionally to enable reliable, compliant supply to United States and international markets
• Own risk management for US sites: conduct quality risk assessments, implement mitigation plans, and ensure escalation/communication to senior leadership.
• Manage budgets and resources for Quality Operations; optimize spend while safeguarding compliance and product quality.
• Lead talent strategy for US Quality Operations: Build, develop, and inspire high-performing Quality teams through strong leadership and continuous improvement

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: Executive