QA Compliance Expert Lead

Job Description Summary

Job Description

Location:

• 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.

Key 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 productrelated 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 decisionmaking
• Support internal and external inspections as a quality system expert ensuring readiness and compliance

Essential Requirements:

• Bachelors 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

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $103600 and $192400 annually

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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

#LI-Hybrid

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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired