Head, Quality Control

Role Summary

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. Designs and implements robust, compliant testing strategies to ensure cGxP adherence to U.S. and EU regulations and to build a scalable QC organization for clinical and commercial manufacturing. This senior, hands-on leadership role has full accountability for QC strategy, compliance, and inspection readiness across clinical and commercial operations. Location: Durham, NC; on-site 5 days a week with eventual relocation to Morrisville, NC.

Responsibilities

• Develops and executes corporate quality policies, practices, procedures, standards, and systems to ensure adherence to DS/DP/FP production and product management in accordance with cGxP and U.S. and EU regulations.
• Oversees the testing and validation strategy, with emphasis on method verification and validation.
• Maintains a robust Environmental Monitoring program that meets regulatory requirements.
• Organizes and directs cross-functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory.
• Builds, leads, and develops QC laboratory teams by hiring and mentoring staff, setting performance expectations, managing external contract vendors, and ensuring efficient utilization of laboratory resources.
• Authors and approves documents required for regulatory submissions.
• Develops, implements, and ensures laboratory procedures and policies are followed.
• Provides presentations explaining laboratory qualification and operations and defends testing results during FDA and other inspections.
• Other duties for which QC is responsible, as assigned.

Qualifications

• Regulatory knowledge: Deep working knowledge of U.S. and EU regulatory requirements, including USP and European Pharmacopoeia standards.
• People and laboratory management experience: minimum 6 years.
• Experience leading operational quality control organizations.
• 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.