Head, Quality Control

Role 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 designs and implements robust, compliant testing strategies to ensure cGxP adherence to U.S. and EU regulations and to build a scalable QC organization capable of supporting clinical and commercial manufacturing. Location: Durham, NC; on-site 5 days a week with no remote work, with eventual relocation to Morrisville, NC.

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.

Qualifications

• 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).

Education

• BS or MS in Chemistry, Pharmacy, or a related natural science; PhD in life sciences preferred.