Specialist, Quality Assurance - QC

Novartis • Durham, NC

9d • $81,200 - $150,800 • Onsite

About The Position

Join Novartis Gene Therapies as a Specialist, Quality Assurance – QC, where you’ll ensure our products meet rigorous safety and quality standards. You’ll oversee analytical method development, monitor lab performance, resolve testing issues, and support regulatory submissions- making a direct impact on patient outcomes. Location: Durham, NC #LI-Onsite Relocation Support: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible.

Requirements

• Bachelor’s degree in scientific discipline.
• Minimum 5 years’ experience in the biotechnology or pharmaceutical industry, which includes preferred experience in quality and/or compliance.
• Strong knowledge of United States Pharmacopeia (USP), International Council for Harmonization (ICH), and European Pharmacopoeia (Ph. Eur.) regulations related to Quality Control.
• Experience implementing lean processes in Good Manufacturing Practice (GMP) lab or manufacturing environments.
• Excellent problem‑solving abilities.
• Strong technical writing skills.
• Ability to work independently, prioritize tasks, and deliver on tight timelines.

Nice To Haves

• At least 2 years directly supporting laboratory functions preferred.

Responsibilities

• Provide QA oversight for analytical method development, qualification, validation, and transfer.
• Monitor method and equipment performance for quality trends and standards adherence.
• Interpret characterization, product release, and stability data for decision-making.
• Support establishment and revision of drug substance and product specifications for regulatory submissions.
• Lead investigations and resolution of out‑of‑specification and out‑of‑trend testing results.
• Support invalid assay and aborted assay investigations.
• Ensure successful accomplishment of business goals through quality support.
• Support QC corrective and preventive actions (CAPAs) and change controls.
• Collaborate with laboratory teams to maintain compliance and reliability.
• Perform other related duties as assigned.
• Provide QA oversight of area with walkthroughs, logbook reviews and general QA oversite responsibilities

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees