Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding. Backed by North Carolina Biotechnology Center.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- 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
More about this role
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...
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