Head, Quality Control

Job Description Summary

Novartis is seeking an experienced Head of Quality Control to provide strategic and operational leadership for QC laboratories supporting Drug Substance, Drug Product, and Finished Product manufacturing, including packaging operations. This role is responsible for designing and implementing robust, compliant testing strategies that ensure cGxP adherence to U.S. and EU regulations while building a scalable QC organization capable of supporting clinical and commercial manufacturing.

 

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 $138,600 and $257,400/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 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

$138,600.00 - $257,400.00

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge