RLT Quality Operations Lead - US (Remote)

Job Description Summary

Job Description

Key Responsibilities:

• Provide strategic leadership and governance for Quality Operations across all US RLT manufacturing sites, ensuring consistent standards, processes, and performance.
• Ensure compliance with applicable regulations and standards (e.g., FDA, cGMP, ICH, Health Authority expectations) and alignment with global Quality policies and procedures.
• Lead inspection readiness and the execution of health authority, customer, and internal inspections; drive robust CAPA, remediation, and continuous improvement.
• 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 ex-US markets.
• 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.
• Drive harmonization of quality systems and digital tools across sites; sponsor standardization, data integrity, and lifecycle management initiatives. Foster Networking and best practice sharing between the sites and regions.
• Lead talent strategy for US Quality Operations: workforce planning, capability building, succession, mentoring, and culture of ownership and continuous improvement.
• Own risk management for US sites: conduct quality risk assessments, implement mitigation plans, and ensure escalation/communication to senior leadership. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Manage budgets and resources for Quality Operations; optimize spend while safeguarding compliance and product quality.

Essential Requirements:

• Bachelor's degree in a scientific discipline (Pharmacy, Chemistry, Chemical Engineering, Radiopharmacy, Nuclear Medicine, or related field).
• 12+ years of progressive Quality/GxP experience in pharmaceuticals or biologics, including 7+ years in radiopharmaceuticals or sterile/aseptic operations.
• Previous experience as a Site Quality Head.
• Must have a 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: building teams, developing talent, leading through influence in matrix organizations.
• Excellent collaboration, communication, and stakeholder management skills; ability to operate at strategic and tactical levels.
• Experience with global supply networks supporting multiple markets and product lifecycle stages
• Approximately 25% travel required.

Desirable Requirements:

• Advanced degree preferred.
• RLT experience strongly preferred.

The salary for this position is expected to range between $204,400 and $379,600 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: novartis-life-handbook.pdf.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

Skills Desired