RLT Head QA Operations US

Band

Job Description Summary

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

• Bachelors 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 $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 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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired