Quality Specialist, Incoming Quality

Novartis • Durham, NC

10h • Onsite

About The Position

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.

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

Nice To Haves

• Collaboration
• Data Integrity
• Leadership
• Operational Excellence

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

Benefits

• health
• life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level