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

Kincell Bio•The Woodlands, TX

4d•Onsite

About The Position

Kincellis Advanced Therapies is seeking a Site Head of Quality to lead the Quality Unit at its site in The Woodlands, Texas. This is the most senior role in the site Quality Unit, with independent authority and enterprise-level accountability. Reporting to the Chief Quality Officer, the Site Head will define, govern, and sustain the site's quality and compliance strategy for clinical and commercial advanced-therapy manufacturing, consistent with applicable GMP requirements, regulatory expectations, client commitments, and patient-safety obligations. The role oversees Quality Control, Quality Operations, Quality Systems, Compliance, and Validation, including batch-disposition governance, inspection readiness, data integrity, and overall quality-system performance. The Site Head will ensure global GMP expectations are translated into effective, controlled, inspection-ready practices and foster a quality culture focused on patient protection, product quality, data integrity, contamination control, deviation prevention, and timely escalation of significant quality risks. The position works across site and corporate functions and with clients, regulators, and auditors. It provides strategic quality input to technology transfer, process and facility readiness, capacity planning, client onboarding, and commercial manufacturing expansion. The leader will also build and develop a qualified Quality organization equipped to support regulated advanced-therapy manufacturing.

Requirements

Bachelor's degree in a scientific, technical, engineering, or related discipline.
At least 10 years of progressive leadership experience in biopharmaceutical, biologics, advanced-therapy, or cell-therapy manufacturing environments.
At least 8 years of direct people leadership experience, including success building, developing, transforming, and scaling high-performing Quality teams.
Senior Quality leadership experience in regulated biopharmaceutical, biologics, advanced-therapy, or cell-therapy manufacturing environments.
Ability to lead an independent Quality Unit, including quality governance, release-decision oversight, escalation management, quality-system performance, inspection readiness, and compliance remediation.
Practical command of GMP regulations, ICH expectations, FDA requirements, USP, EP, JP, and applicable global regulatory standards.
Credibility engaging regulatory agencies, client auditors, and third-party inspectors.
Track record of building and sustaining quality systems, governance structures, and risk-based decision frameworks that withstand regulatory scrutiny and support compliant operations.
Executive presence, sound regulatory judgment, and ability to communicate complex quality matters clearly, escalate appropriately, and serve as a credible Quality authority to site and corporate leadership, clients, and regulators.

Nice To Haves

Advanced degree.
Cell-therapy experience.

Responsibilities

Provide independent Quality Unit leadership, establishing quality governance, decision rights, escalation pathways, and resources that support compliant manufacturing, product quality, patient safety, and regulatory commitments.
Maintain oversight of Quality Control, Quality Operations, Quality Systems, Compliance, and Validation functions.
Build and strengthen client relationships and serve as the site escalation point for client-facing quality issues.
Advance a risk-based quality management system through governance, management review, quality metrics, quality risk management, CAPA effectiveness, change control, deviation management, and continuous improvement.
Sustain inspection readiness through controlled GMP systems, accurate records, contemporaneous documentation, data-integrity oversight, audit preparedness, and timely remediation of compliance gaps.
Champion a prevention-focused quality culture grounded in patient protection, contamination control, risk management, transparent escalation, 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 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.
Represent site Quality with executive leadership, clients, regulators, and auditors, 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 needed for regulated advanced-therapy manufacturing.