Job Description Summary

At Novartis, quality is not just a standard, it is a promise to patients. As a Quality Specialist, Incoming Quality Assurance, you will play a critical role in safeguarding product integrity from the very first point of entry, ensuring that incoming materials meet the highest quality and compliance expectations. You will partner closely with operations, suppliers, and quality systems teams to drive excellence, support continuous improvement, and maintain a strong state of control across incoming quality processes. This is an opportunity to apply your expertise in a highly visible role where your decisions directly support patient safety and the delivery of life-changing therapies.

Job Description

Location:

This position will be located in Durham, NC and will be an onsite role.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities:

Serve as quality subject matter expert for site systems, including enterprise resource planning, laboratory, and document control platforms
Review and approve master data for raw materials, consumables, and finished products to ensure regulatory compliance
Provide quality oversight and final disposition of incoming materials, ensuring adherence to quality and safety standards
Partner with suppliers to ensure incoming documentation meets Novartis requirements and established specifications
Maintain compliant quality documentation, standard operating procedures, and support change controls and corrective actions
Oversee warehousing quality activities, including walkthroughs, alarm review, inventory management, and return inspections
Support audits, health authority inspections, and continuous improvement initiatives to strengthen quality systems

Essential Requirements:

Bachelor’s degree in a scientific discipline such as biology, chemistry, or a related field
Minimum of three years of experience working in a quality assurance position within a regulated environment
Strong knowledge of global quality regulations, including United States Pharmacopeia, International Council for Harmonization, and European Pharmacopoeia standards
Proven experience supporting quality assurance activities in a good manufacturing practice laboratory or manufacturing setting
Demonstrated ability to review, approve, and maintain quality documentation and standard operating procedures
Strong problem-solving, critical thinking, and decision-making skills in regulated environments
Excellent technical writing skills with the ability to communicate clearly and precisely
Ability to work independently, manage competing priorities, and deliver results within tight timelines

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $43.08 and $80.00 per hour

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis 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.

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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.

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 us.reasonableaccommodations@novartis.com 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.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence

Welcome to where we thrive together

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

Be aware of fake job advertisements and job offers

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If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information.

Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams.

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Quality Specialist, Incoming Quality

About the role