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

Job Description

Job Description

Job Summary

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.

The Role

• 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.

The Candidate

• Bachelor's degree in a scientific, technical, engineering, or related discipline required; advanced degree preferred.
• 10+ years of progressive leadership experience in biopharmaceutical, biologics, advanced therapy, or cell therapy manufacturing environments; cell therapy experience strongly preferred.
• 8+ years of direct people leadership experience, including demonstrated success building, developing, transforming, and scaling high-performing Quality teams.
• Demonstrated senior Quality leadership experience in regulated biopharmaceutical, biologics, advanced therapy, or cell therapy manufacturing environments, with cell therapy experience strongly preferred.
• Proven ability to lead an independent Quality Unit, including quality governance, release decision oversight, escalation management, quality system performance, inspection readiness, and compliance remediation.
• Deep, practical command of GMP regulations, ICH expectations, FDA requirements, USP, EP, JP, and applicable global regulatory standards, with demonstrated 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 operational performance.
• Executive presence, sound regulatory judgment, and the ability to communicate complex quality matters clearly, escalate appropriately, and serve as a credible Quality authority to site leadership, corporate leadership, clients, and regulators.

Position Benefits

• Opportunity to serve as the accountable site Quality leader for a growing regulated cell therapy CDMO
• Direct visibility to executive leadership and meaningful influence on quality governance, inspection readiness, compliance performance, and patient protection
• Opportunity to build, strengthen, and scale Quality capabilities that support clinical and commercial manufacturing under GMP expectations
• Collaborative, cross-functional environment with strong partnership across Manufacturing, Technical Operations, Program Management, Business Development, and client-facing teams
• Competitive benefits package supporting health, wellness, financial security, and overall well-being
• 401K with strong employer match
• Tuition reimbursement
• Employee referral bonuses
• Flexible work schedules, PTO and paid holidays
• Opportunity to help advance novel cell therapies from benchtop to bedside

"At Kincellis Advanced Therapies (formerly Cellipont Bioservices), we are seeking Quality leaders who bring scientific rigor, regulatory discipline, and an unwavering commitment to patient protection, product quality, data integrity, and sustained GMP compliance."

Notice to Agency and Search Firm Representatives

Kincellis Advanced Therapies does not accept unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Kincellis Advanced Therapies employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Kincellis Advanced Therapies. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.