RLT Quality Operations Lead US (Remote)

Job Description Summary

Job Description

Key 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.

Essential Requirements

• Bachelors 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.

The salary for this position is expected to range between $168000 and $312000 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 -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 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 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 or call 1 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