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Band Level 6 Job Description Summary Job Title: RLT Head Quality Assurance Operations US #LI-Onsite Location: Indianapolis, Indiana, United States 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. Job Description Key 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 Essential 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. Desirable requirements Prior experience with site start-up or rapid site expansion Experience or formal training in radioligand therapies, radiopharmaceuticals, or radiation safety 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. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $168,000.00 - $312,000.00 Skills Desired Business Partnering, Business Strategy, Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Decision Making, Digital saviness, Finance Acumen, Leadership, Smart Risk Taking, Stakeholder Management, Storytelling, Strategic Planning, Strategic Thinking Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .