Site Quality Head, Texas (AD level)

Novartis • Durham, CA

1d • Onsite

About The Position

At Novartis, we are redefining the future of cancer care through Radioligand Therapy (RLT) - a powerful convergence of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are building a team of passionate, purpose driven quality leaders who are inspired to make a meaningful impact. This is a unique opportunity to play a critical role in the start up and ongoing quality operations of a new RLT manufacturing site, helping ensure the delivery of life changing therapies to patients around the world. 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.

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.

Nice To Haves

• Prior experience with site start-up or rapid site expansion
• Experience or training in Radioligand Therapies, radiopharmaceuticals and/or radiation safety.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director