Site Quality Head, Texas (AD level)

Defense Mechanics Inc; Denton (TX); On-site; USD 138,600 - 257,400; Full time

Benefits offered by this job

401(k) with company contribution

Performance-based cash incentive

Comprehensive health benefits

Job summary

Defense Mechanics Inc in Denton, Texas seeks a Site Quality Head at the Associate Director level. This role involves leading the quality foundation for a new RLT manufacturing site, ensuring compliance and excellence in operations.

The Site Quality Head will shape strategies and lead a passionate Quality team, focusing on rigorous compliance and continuous improvement. The position offers a competitive salary and numerous benefits, making a significant impact in cancer care.

Qualifications

• Ten years of experience in a GMP pharmaceutical manufacturing environment.
• In-depth knowledge of cGMP, FDA regulations, and ICH regulations.
• Demonstrated leadership in matrix organizations.

Responsibilities

• Lead site quality strategy and governance to meet standards.
• Build, coach, and develop the Quality team.
• Ensure compliance in planning, commissioning, qualification, and validation activities.

Skills

Business Acumen

Collaboration

Communication Skills

Problem Solving Skills

Leadership

Education

Bachelor's degree in life sciences or related scientific discipline

Job description

Job Title

Site Quality Head (Associate Director level)

Location: Denton, Texas – Onsite

Job Summary

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.

The Site Quality Head – Texas will shape the quality foundation for a new RLT manufacturing site, combining rigorous compliance with strong, visible leadership to deliver time‑sensitive therapies reliably and safely. You will 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.

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 start‑up, 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, United States Food and Drug Administration regulations, and International Council for Harmonisation 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.

Benefits and Compensation

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 relevant skills and experience, and will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Compensation includes a performance‑based cash incentive and, depending on the level of the role, eligibility for annual equity awards.

US‑based eligible employees 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. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays and other leaves.

Skills Desired

• Business Acumen, Business Strategy, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital Saviness, Finance Acumen, Health & Safety Regulations Knowledge, Leadership, Manufacturing Production, Problem Solving Skills, Regulatory Requirements Knowledge, Risk Management, Smart Risk Taking, Stakeholder Management, Storytelling, Technology Transfer.

EEO Statement

The Novartis Group of Companies is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.