QA Compliance Expert / Lead

Novartis • Durham, CA

18h • Hybrid

About The Position

Step into a role where quality leadership directly shapes the future of gene therapies. As a QA Compliance Expert / Lead, you will be a trusted voice in ensuring that innovative medicines are developed and commercialized with the highest standards of quality, integrity, and compliance. Partnering closely with manufacturing, development, and global quality teams, you will lead critical quality system activities, mentor others, and drive meaningful improvements that safeguard patients and advance Novartis’ mission to reimagine medicine. This position will be located in Durham, NC and will be a hybrid role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Requirements

• Bachelor’s degree in a relevant scientific or technical discipline
• Minimum eight years of quality assurance experience, including at least five years in pharmaceutical environments
• Expert knowledge of quality systems, including change control and nonconformance management
• Proven experience reviewing quality systems data to identify compliance and data consistency issues
• Demonstrated expertise in data integrity principles and regulatory expectations
• Advanced understanding of United States Food and Drug Administration and European Medicines Agency regulations
• Hands-on experience authoring, reviewing, and owning standard operating procedures
• Strong written and verbal communication skills, including technical writing proficiency

Nice To Haves

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

Responsibilities

• Lead site quality system processes supporting development and commercialization of gene therapy medicines
• Serve as subject matter expert for change control, nonconformance, and documentation programs
• Drive consistent execution of investigations, root cause analysis, and corrective and preventive actions
• Review and approve change controls and nonconformances in alignment with quality system requirements
• Mentor and train quality assurance colleagues on quality system processes and best practices
• Partner with manufacturing and operations on product‑related investigations and deviations
• Own, author, and maintain standard operating procedures to ensure regulatory compliance
• Monitor, analyze, and trend quality system metrics to identify improvement opportunities
• Lead site forums and review boards supporting quality alignment and decision‑making
• Support internal and external inspections as a quality system expert, ensuring readiness and compliance

Benefits

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

What This Job Offers

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