Sobre esta vaga de Site Head of Quality (The Woodlands, TX) Cell Therapy CDMO na Kincell Bio, LLC
Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.
For more information, visit our website at www.kincellis.com.
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.
#LI-Onsite
Kincellis Advanced Therapies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincellis Advanced Therapies complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
NOTE TO EMPLOYMENT AGENCIES: Kincellis Advanced Therapies values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.
