Site Head of Quality (The Woodlands, TX) Cell Therapy CDMO

The role

The Site Head of Quality will lead the Quality Unit in The Woodlands, TX. This leader will define and sustain the site quality and compliance strategy to support clinical and commercial advanced therapy manufacturing.

What you will do

• Provide independent Quality Unit leadership for the site.
• Maintain oversight of Quality Control, Quality Operations, Quality Systems, Compliance, and Validation functions.
• Build and strengthen client relationships and serve as a point of escalation.
• Advance a risk-based quality management system.
• Ensure the site sustains a state of inspection readiness.
• Champion a prevention-focused quality culture.
• Partner with Manufacturing, Technical Operations, Program Management, Business Development, and Supply Chain teams.
• Provide strategic Quality input into technology transfer, process and facility readiness, and capacity planning.
• Represent the site Quality function with executive leadership, clients, regulators, and auditors.
• Build, develop, and lead a qualified Quality organization.

Required qualifications

• Bachelor's degree in a scientific, technical, engineering, or related discipline
• 10+ years of progressive leadership experience in biopharmaceutical, biologics, advanced therapy, or cell therapy manufacturing environments
• 8+ years of direct people leadership experience
• Demonstrated senior Quality leadership experience in regulated biopharmaceutical, biologics, advanced therapy, or cell therapy manufacturing environments
• Proven ability to lead an independent Quality Unit
• Deep, practical command of GMP regulations, ICH expectations, FDA requirements, USP, EP, JP, and applicable global regulatory standards

Nice to have

• advanced degree
• cell therapy experience

About the company

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers. The company has facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas.