Head, Quality Control

Job Description Summary

Job Description

#LI-Onsite

Location: Durham NC

This role is on-site 5 days a week and does not have the ability to work remotely. This role is located in Durham NC and will eventually move to Morrisville NC at a later date

Key Responsibilities:

• Develops and executes corporate quality policies practices procedures standards and systems necessary to ensure adherence to DS/DP/FP production and product management in accordance with the cGxP compliance to U.S. and EU regulations.

• Oversees the testing and validation strategy with a concentrated focus on method verification and validation.

• Maintains a robust Environmental Monitoring program that meets U.S./EU and other applicable regulatory requirements.

• Organizes and directs cross functional relationships with Manufacturing Engineering MS&T Quality Assurance and Regulatory.

• Build lead and develop QC laboratory teams by hiring and mentoring staff setting performance expectations manage external contract vendors and ensuring efficient utilization of laboratory resources.

• Authors and approve documents required for regulatory submissions.

• Develops implements and ensures laboratory procedures and policies are followed.

• Provides presentations explain laboratory qualification and operations and defend testing results during FDA and other inspections.

• Other duties for which QC is responsible as assigned.

Essential Requirements:

• BS or MS in Chemistry Pharmacy or a related natural science with a minimum of 10 years of experience in a cGMP laboratory environment; PhD in life sciences preferred.

• Deep working knowledge of U.S. and EU regulatory requirements including USP and European Pharmacopoeia standards.

• Minimum of 6 years of people and laboratory management experience.

• Prior proven experience leading operational quality control organizations.

• Demonstrated experience establishing startup lab facilities supporting clinical and/or commercial manufacturing.

• Direct experience supporting and leading regulatory agency inspections.

• Fluency in English (written and verbal)

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $138600 and $257400/year. 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 -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.

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