Site Quality Head, Texas (AD level)
Novartis
June 27, 2026
On-site
Denton, TX
$138,600 - $257,400 USD yearly
Operations
Key Responsibilities:
- Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
- Build, coach, and develop the Quality team.
- 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 CAPA 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 to drive continuous improvement and timely escalation of risks.
Essential Requirements:
- Bachelor’s degree in life sciences or related scientific discipline.
- 10 years’ GMP pharmaceutical manufacturing experience (including laboratory operations and aseptic experience), plus at least 3 years combined relevant experience in Quality Assurance and/or Quality Control.
- In-depth knowledge of cGMP, US FDA regulations, and ICH regulations; understanding of US Pharmacopeia, European Pharmacopeia, and ACS standards.
- Proven success leading health authority inspections and delivering sustained compliance improvements.
- Demonstrated leadership in matrix organizations; strong communication, organization, and stakeholder management skills.
- Experience applying continuous improvement methods (Lean Six Sigma, Total Quality Management, 5S).
Desirable Requirements:
- Prior experience with site start-up or rapid site expansion.
- Experience or training in Radioligand Therapies, radiopharmaceuticals, and/or radiation safety.
- Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
- Build, coach, and develop the Quality team.
- 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 CAPA 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 to drive continuous improvement and timely escalation of risks.
Essential Requirements:
- Bachelor’s degree in life sciences or related scientific discipline.
- 10 years’ GMP pharmaceutical manufacturing experience (including laboratory operations and aseptic experience), plus at least 3 years combined relevant experience in Quality Assurance and/or Quality Control.
- In-depth knowledge of cGMP, US FDA regulations, and ICH regulations; understanding of US Pharmacopeia, European Pharmacopeia, and ACS standards.
- Proven success leading health authority inspections and delivering sustained compliance improvements.
- Demonstrated leadership in matrix organizations; strong communication, organization, and stakeholder management skills.
- Experience applying continuous improvement methods (Lean Six Sigma, Total Quality Management, 5S).
Desirable Requirements:
- Prior experience with site start-up or rapid site expansion.
- Experience or training in Radioligand Therapies, radiopharmaceuticals, and/or radiation safety.