QC Stability Manager

About the role

The QC Stability Manager is responsible for leading and maintaining stability programs that support clinical and commercial cell and gene therapy products. This role serves as the stability subject matter expert and primary point of contact for all stability-related activities across internal teams, contract manufacturing organizations, and contract testing laboratories. The position plays a critical role in ensuring robust stability strategies, compliant execution of studies, and high-quality data to support shelf-life, storage conditions, and regulatory submissions for advanced therapies.

Responsibilities

• Manage and oversee stability programs and studies that support clinical and commercial cell therapy products, ensuring alignment with quality and regulatory expectations.
• Author, review, and approve stability protocols, study plans, reports, and all related documentation to ensure scientific soundness and regulatory compliance.
• Coordinate the stability program end-to-end, including long-term, accelerated, in-use, freeze-thaw, transport, and comparability studies, driving timely execution and adherence to approved protocols.
• Review, analyze, and trend stability data to support shelf-life assignments, expiry dating, storage conditions, and product quality decisions.
• Oversee stability activities conducted by contract manufacturing organizations, external suppliers, and contract testing laboratories, ensuring compliance with quality standards and regulatory requirements.
• Monitor overall stability program performance, maintain study tracking systems, and proactively communicate study status, data trends, and risks to key stakeholders.
• Support batch disposition activities by reviewing quality control data and providing stability-related input to product release decisions.
• Lead or support investigations related to stability failures, out-of-specification (OOS) and out-of-trend (OOT) results, laboratory deviations, and product quality issues, ensuring thorough root cause analysis and effective corrective actions.
• Author and review stability-related content for regulatory documentation and support regulatory inspections, audits, and submissions.
• Collaborate closely with internal cross-functional groups, including CMC and Quality, to align stability strategies with overall product development and commercialization plans.
• Engage with external partners, including CDMOs/CMOs and contract laboratories, to coordinate stability activities, resolve issues, and maintain strong communication channels.