Director, Analytical Product Quality

Position Summary

The Director of Analytical Product Quality provides quality oversight of analytical development activities throughout the product development lifecycle for Cell & Genetic therapy programs, including QA support for method validation and analytical transfer to contract manufacturers, test labs, and internal laboratories.

• Maintain QA oversight of method development and qualification activities.
• Oversee the stability program to ensure compliance with internal procedures, EU/US regulatory standards, and cGMPs.
• Lead quality review of analytical development activities, including method qualification/validation protocols and reports.
• Support development of analytical strategy with cross-functional stakeholders.
• Drive investigations for out-of-specifications, root cause analysis, and CAPA implementation.
• Provide primary oversight for the reference standard program.
• Lead/participate in development of global Quality system standards and SOPs.
• Review/approve documentation, including deviation investigations and change control.
• Support regulatory submission review (e.g., INDs) and responses to regulatory questions as assigned.
• Identify compliance risks/gaps and implement mitigating controls.
• Support management of contract test labs, including Quality Agreements.
• Lead/participate in program quality/technical projects and continuous improvement aligned to FDA/EMA/SOPs.

BS/MS/PhD in engineering/life sciences or relevant equivalent background.

Typically 10+ years in biotech/regulated pharma (manufacturing, QA, and/or QC).

• In‑depth global regulatory/GxP knowledge for Cell & Gene therapy/Biologics; ICH and EU/FDA regulations.
• Analytical method development experience for cellular programs and clinical product development.
• Root Cause Analysis and Operational Excellence (LEAN, DMAIC, Six Sigma); risk management and strong communication/influencing.

Up to 5% travel.