Site Head of Quality ) Cell Therapy CDMO

Kincellis Advanced Therapies (formerly Cellipont Bioservices) is seeking a Site Head of Quality to oversee and lead The Woodlands, TX Quality Unit. This individual will serve as the most senior level in The Woodlands, TX Quality unit. This leader will define, govern, and sustain the site quality and compliance strategy required to support clinical and commercial advanced therapy manufacturing in accordance with applicable GMP requirements, regulatory expectations, client commitments, and patient safety obligations.

Reporting to the Chief Quality Officer, the Site Head of Quality will have independent authority and enterprise-level accountability for the site's Quality unit. This role will have oversight of Quality Control, Quality Operations, Quality Systems, Compliance, Validation functions. Including, but not limited to batch disposition governance, inspection readiness, data integrity, and overall quality system performance. The successful candidate will bring the regulatory judgment and operational discipline required to ensure that global GMP expectations are translated into effective, controlled, and inspection‑ready site practices.

This leader will reinforce a quality culture that prioritizes patient protection, product quality, data integrity, contamination control, deviation prevention, and timely escalation of significant quality risks, while ensuring that site practices remain aligned with regulatory commitments and sustained compliance expectations.

• Provide independent Quality Unit leadership for the site, ensuring quality governance, decision rights, escalation pathways, and resources support compliant manufacturing, product quality, patient safety, and regulatory commitments.
• Maintain oversight of Quality Control, Quality Operations, Quality Systems, Compliance, Validation functions.
• Strategically build and strengthen client relationships and serve as the point of escalation for client‑facing quality issues at the site.
• Advance a risk‑based quality management system through effective governance, management review, quality metrics, quality risk management, CAPA effectiveness, change control discipline, deviation management, and continuous improvement.
• Ensure the site sustains a state of inspection readiness through controlled GMP systems, accurate records, contemporaneous documentation practices, data integrity oversight, audit preparedness, and timely remediation of compliance gaps.
• Champion a prevention‑focused quality culture grounded in patient protection, contamination control, quality risk management, transparent escalation, and decisions based on objective evidence and regulatory expectations.
• Partner with Manufacturing, Technical Operations, Program Management, Business Development, Supply Chain, and client‑facing teams to define quality requirements, confirm GMP readiness, evaluate quality risks, and support compliant program execution.
• Provide strategic Quality input into technology transfer, process and facility readiness, capacity planning, client onboarding, and commercial manufacturing expansion to ensure compliance expectations are embedded before execution.
• Represent the site Quality function with executive leadership, clients, regulators, and auditors by clearly communicating quality system performance, inspection readiness, significant quality events, emerging risks, and remediation plans.
• Build, develop, and lead a qualified Quality organization with the technical capability, decision‑making discipline, documentation standards, and compliance mindset required to support regulated advanced therapy manufacturing.

• Bachelor's degree in a scientific, technical, engineering, or related discipline required; advanced degree preferred.
• 10+…