About the Role
Key Responsibilities
- Lead day-to-day operations within the QA Compliance function and develop a high-performing quality team.
- Oversee Product Quality Review and Annual Product Quality Review planning, execution, and compliance activities.
- Support qualification and validation programs through planning, guidance, and quality review activities.
- Drive implementation and continuous improvement of quality systems, including documentation management processes.
- Coordinate corrective and preventive action activities and ensure timely follow-up on quality commitments.
- Lead audit and inspection readiness efforts, including support during regulatory and internal inspections.
- Review change controls, monitor compliance metrics, and ensure adherence to regulatory and data integrity requirements.
Essential Requirements
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Biochemistry, or another scientific discipline.
- At least 5 years of Quality Assurance or Quality Control experience within pharmaceutical manufacturing environments.
- Demonstrated experience leading teams and developing talent within a regulated quality organization.
- Strong knowledge of cGMP and GxP Quality requirements.
- Experience supporting audits, inspections, change controls, corrective and preventive actions, and quality systems.
- Proven ability to manage compliance risks, analyze quality metrics, and collaborate across complex organizations.
Desirable Requirements
- Experience serving as a liaison with Health Authorities and supporting regulatory communications.
- Demonstrated experience driving quality improvements through key performance indicator analysis and compliance trending.
The salary for this position is expected to range between $114,100 and $211,900 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.
#LI-Onsite
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)