Job Description Summary

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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Salary Range

$89,600.00 - $166,400.00

 

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence