Head, Quality Control

Novartis • Durham, NC

4d • Onsite

About The Position

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

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)

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager