Site Quality Head, Texas (AD level)
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.
Site Quality Head, Texas (AD level)
As the Site Quality Head Texas, you’ll shape the quality foundation for a new Radioligand Therapy manufacturing site—combining rigorous compliance with strong, visible leadership to help deliver time‑sensitive therapies reliably and safely. You’ll lead and develop a high-performing Quality organization, partner closely with site and global stakeholders, and set the standard for inspection readiness, robust management of product quality issues, and continuous improvement—so the site starts up strong and scales with confidence.
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.
