QA Compliance Specialist

Novartis • Durham, NC

14h • Hybrid

About The Position

In this role, you’ll be at the heart of ensuring quality, compliance, and trust as we advance innovative gene therapies for patients worldwide. As a QA Compliance Specialist, your expertise will directly shape how quality systems are applied, strengthened, and continuously improved across the site—supporting both development and commercialization. You’ll partner closely with cross-functional teams, influence critical decisions, and serve as a trusted voice on compliance, helping turn complex challenges into clear, risk-based solutions that protect patients and products alike.

Requirements

• Bachelor’s degree in life sciences, chemistry, or related field, with significant experience in regulated manufacturing environments
• Proven experience in Quality Assurance within pharmaceutical, biotechnology, or gene therapy manufacturing
• Strong working knowledge of quality systems, including change control, non-conformance management, and deviation handling
• Demonstrated experience applying data integrity principles and ensuring compliance with current regulatory expectations
• Hands-on experience supporting Good Manufacturing Practice operations through quality management system execution
• Solid understanding of regulatory guidelines and expectations from global health authorities
• Experience reviewing, authoring, and approving standard operating procedures and quality documentation
• Ability to work independently, manage multiple priorities, and communicate clearly across technical and operational teams

Nice To Haves

• Collaboration
• Communication Skills
• Data Integrity
• Dealing With Ambiguity
• Decision Making
• Digital saviness
• Leadership
• Problem Solving Skills
• Project Management
• Regulatory Requirements knowledge
• Risk Management

Responsibilities

• Establish and maintain site quality system processes supporting development and commercialization of advanced gene therapy medicines
• Drive consistent execution of change control and non-conformance programs aligned with global quality system standards
• Lead investigations, root cause analysis, and timely corrective and preventive actions using a risk-based approach
• Serve as subject matter expert for change control, non-conformance, and quality documentation programs
• Lead non-conformance and change control review board meetings, ensuring effective governance and decision-making
• Review, approve, and author standard operating procedures to ensure regulatory and quality system compliance
• Analyze quality system metrics, trend performance, and present actionable insights to drive continuous improvement
• Provide guidance and training to site users on quality system processes and expectations
• Partner with manufacturing and operations on product investigations, deviations, and compliance activities
• Ensure adherence to Good Manufacturing Practice requirements and support inspection readiness across the site

Benefits

• health
• life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• 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