About the Role
Key Responsibilities
- Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
- Build, coach, and develop the Quality team, strengthening capability, engagement, and safe working practices.
- Drive plant startup, expansions, and technology transfer, ensuring compliant planning, commissioning, qualification, and validation activities.
- Lead inspection readiness and represent the site during health authority, corporate, and internal audits.
- Oversee deviations, investigations, out-of-specification events, and corrective and preventive actions through effective closure.
- Partner with Manufacturing and cross-functional leaders to enable compliant, efficient operations and risk-based decision making.
- Define and monitor site quality performance indicators, driving continuous improvement and timely escalation of risks.
Essential Requirements
- Bachelor’s degree in life sciences or a related scientific discipline.
- Ten years of experience in a GMP pharmaceutical manufacturing environment, including laboratory operations and Aseptic experience, and at least three years of combined relevant experience in Quality Assurance and/or Quality Control roles.
- In-depth knowledge of cGMP and United States Food and Drug Administration regulations and International Council for Harmonization regulations. Understanding of US Pharmacopeia, European Pharmacopeia, and American Chemical Society standards.
- Proven success leading health authority inspections and delivering robust remediation and sustained compliance improvements.
- Demonstrated leadership in matrix organizations with excellent communication, organizational, and stakeholder management skills.
- Experience applying continuous improvement methods such as Lean Six Sigma, Total Quality Management, and 5S workplace organization.
Desirable Requirements
- Prior experience with site start-up or rapid site expansion
- Experience or training in Radioligand Therapies, radiopharmaceuticals and/or radiation safety.
The salary for this position is expected to range between $ 138,600 and $257,400 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.
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.
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