Specialist, Quality Assurance - QC

Job Description Summary

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.

 

Job Description

Key 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

Essential 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. 
• At least 2 years directly supporting laboratory functions preferred.
• 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.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $39.03 and $72.50/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.

 

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 [email protected] 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

$81,200.00 - $150,800.00

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence