Site Quality Head, Texas (AD level)

Novartis Group Companies; Durham (NC); On-site; USD 138,600 - 257,400; Full time

Benefits offered by this job

Comprehensive health benefits

401(k) with company contribution

Generous time-off package

Job summary

A global leader in pharmaceutical manufacturing is looking for a Site Quality Head to supervise quality operations at a new Radioligand Therapy manufacturing site. The ideal candidate should have at least 10 years of experience in GMP environments, along with strong leadership and compliance management skills. This role is vital for ensuring the start-up of quality operations, improving safety measures, and maintaining compliance with industry standards. A robust benefits package is included, emphasizing work-life balance.

Qualifications

• 10 years of experience in a GMP pharmaceutical manufacturing environment.
• In-depth knowledge of cGMP and FDA regulations.
• Experience applying continuous improvement methods, such as Lean Six Sigma.

Responsibilities

• Lead site quality strategy to meet Novartis standards.
• Build and develop the Quality team.
• Drive plant start-up and expansions ensuring compliance.

Skills

Business Acumen

Collaboration

Communication Skills

Problem Solving Skills

Leadership

Education

Bachelor's degree in life sciences or a related scientific discipline

Job description

Job Description Summary

Job Title: Site Quality Head (Associate Director level)

Location: Dallas/Fort Worth, Texas

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.

Job Description

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 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.

Salary Range

$138,600.00 - $257,400.00

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 such as relevant skills and experience, and upon joining Novartis it 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.

Skills Desired

Business Acumen, Business Strategy, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital Savviness, 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

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to [e-mail] or call +1(877)395‑2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. 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.

Benefits

We offer a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, generous time‑off, and other benefits to support work‑life balance.

Additional Information

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