Spotlight on Excellence: Cell Therapy Quality Assurance Team

The value of a QA team at a cell therapy CDMO lies in their ability to ensure that every aspect of the development and manufacturing process is performed with the highest level of quality, safety, and regulatory compliance. Their role ensures that the products manufactured are safe, effective, and compliant with all regulatory requirements. Their role is essential to building confidence with clients, ensuring that products meet the stringent demands of the cell therapy industry.

At Excellos, quality isn’t just a standard—it’s our foundation. Our Quality Assurance (QA) and Regulatory teams play a critical role in ensuring that every process, material, and product meets the highest Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) standards, driving compliance, consistency, and continuous improvement.

Our Commitment to Quality

With Excellos QA and Regulatory teams at your side, you gain access to standardized procedures, control measures, and documentation that ensure a consistent, reproducible product that meets regulatory requirements. At Excellos, we are committed to building a true partnership with clients, with a focus on Patients First. Products and processes are managed throughout their lifecycle for continuous improvement opportunities in partnership with the client.

Excellos has developed a comprehensive Quality Management System (QMS) that:

• Complies with regulations while adapting to business needs
• Operates with agility and is driven by skilled, quality-focused professionals
• Aligns with strategic imperatives to meet stakeholder and industry expectations
• Integrates risk-based decision-making at all levels of leadership
• Is reviewed quarterly to track progress and ensure continuous improvement

Excellos Quality System

Our transition from San Diego Blood Bank’s Quality Systems involved a full-scale assessment and optimization to ensure compliance with cGMP and GTP standards. Today, our Quality System consists of:

• Quality Systems — Establishing quality standards, ensuring QMS compliance, and managing documentation across the organization
• QA Operations — Providing daily support to Manufacturing and Supply Chain, managing product and material disposition, approvals, change controls, deviations/CAPA, and complaints
• Compliance — Leading internal and external audits, regulatory inspections, and client audits
• Quality Control — Overseeing in-process testing, product release, stability programs, and environmental monitoring (spotlight on this team to follow soon)

Meet the Team

Cell Therapy Quality Assurance Team

Each member of our QA team brings unique expertise and dedication to Excellos. They work behind the scenes to ensure that our operations are efficient, compliant, and consistently delivering the highest quality results.

Heather Burnell, VP of Quality and Regulatory Affairs

Heather is a Quality Professional with over 34 years of experience in the biotech industry, and over 9 years of experience in cell and gene therapy. She has experience leading Quality teams for large multi-product facilities and startup environments. Prior to Excellos, Heather held roles at CDMOs as Head of Manufacturing and MSAT for Abzena, and Head of Quality at SAFC (now Millipore Sigma). Heather held a variety of QC/QA roles at Amgen in her 22 years there, including leadership roles in Site and Corporate Quality as well as several years leading regulatory inspections, both pre-approvals and biennials. Under Heather’s leadership, Excellos has built a highly skilled, agile Quality Team and Systems that are focused on marrying cGMP and GTP standards to ensure quality and patient safety, while building strong working relationships with clients to achieve their goals.

Rachel Kim, Sr QA Operations Specialist

Rachel joined Excellos in 2022 and brings over 4 years of quality assurance experience in the biotech industry, with expertise in ensuring compliance and integrating quality into manufacturing processes. She has extensive experience in batch release, reviewing QC data, conducting real-time batch record reviews, and supporting manufacturing operations with a focus on maintaining cGMP standards. Prior to Excellos, Rachel held QA roles at Abzena, where she oversaw manufacturing QA teams, implemented process improvements, and trained quality personnel to enhance compliance and reduce documentation errors. Rachel’s analytical mindset, attention to detail, and ability to adapt to shifting priorities make her an essential contributor to the success of Excellos’ QA operations.

Victor Almanza, Sr QA Operations Specialist

Victor has been an integral part of Excellos since its inception, bringing a wealth of experience from his years at the San Diego Blood Bank. As one of the original team members who transitioned to Excellos, Victor’s deep understanding of cell therapy processes and his hands-on expertise in laboratory operations have been invaluable in shaping our quality systems. Now as a Sr. QA Operations Specialist, Victor leverages his extensive knowledge to ensure compliance, oversee batch record reviews, and support manufacturing operations. His commitment to quality, combined with his historical knowledge of our systems, makes him a trusted resource and a key contributor to Excellos’ ongoing success.

Brandon Braun, Sr QA Raw Materials Specialist

We’re excited to welcome our newest member of the team, Brandon, as our QA Sr. Specialist, Raw Materials. He joins us with 15 years of experience in Biopharmaceuticals. He has held roles in a broad range of departments including Facilities, Materials, Environmental Monitoring, and key positions within QA as a Document Control Manager and Sr. QA Specialist. In this role, Brandon will apply that broad expertise within the QA department in support of Excellos’ QMS. We’re thrilled to have Brandon on board and look forward to the impact he’ll make in strengthening our quality operations.

Brock Jones, QA Specialist

Brock joined Excellos in January 2022, spending his first two and a half years as a GXP Manufacturing Associate before transitioning into his current role as a QA Specialist. His experience in GXP Manufacturing has provided him with a strong foundation in compliance, process understanding, and troubleshooting—skills that directly support his success in quality. Brock’s expertise enhances our QA team’s ability to maintain high standards and ensure operational excellence at Excellos.

Rhenell Hernandez, Document Associate II

With 4 years of document control experience in the biotech industry, Rhenell has developed a solid understanding of the critical role document management plays in ensuring compliance, quality assurance, and regulatory adherence. He thrives on problem-solving and continually looks for ways to optimize processes, improve efficiency, and reduce errors. Rhenell’s dedication to quality and his drive to enhance operational processes make him a valuable member of our QA team, ensuring that Excellos’ documentation systems are running smoothly and in full compliance.

Industry-Leading Compliance & Accreditation

In addition to our robust Quality System, Excellos holds key licensures to support our high standards:

     ✔ California State Laboratory Field Services license for the production of biologics

     ✔ California State Tissue bank license

     ✔ FDA Cell and Tissue Registration

Our Commitment to Excellence

Whether managing documentation, overseeing quality control, or leading regulatory inspections, our QA team is a cornerstone of Excellos’ success. Their expertise ensures that while we are a growing company, we operate with the precision, reliability, and compliance of an industry leader.

We’re proud to highlight the exceptional work of this team and their impact on delivering high-quality cell and gene therapy solutions.