Adrienne B. Mendoza, Mha Email and Phone Number

As the Chief Operating Officer (COO) at South Texas Blood & Tissue, I have the privilege of overseeing the organization's day-to-day operations and strategic plans. We serve over 100 hospitals across 48 counties, as well as collaborate with numerous developers of Tissue Allografts and Advanced Therapies in Regenerative Medicine. My leadership is dedicated to ensuring the safety and accessibility of critical blood, cells, and tissues to meet the needs of patients in our community.During my tenure, I've achieved significant milestones, including the development of a highly influential team in our field. Our efforts have led to improvements in donor outreach initiatives, enhancing donor experience and retention, improving employee satisfaction, and streamlining operational processes to keep pace with the growing demand for our life-saving services.My approach to success centers around collaboration. I've fostered strong partnerships with healthcare providers, donors, and stakeholders, which have expanded our impact and outreach within the community.

While I held the role of VP, Blood Operations for South Texas Blood & Tissue, I was responsible for overseeing the operational resources to achieve a stable regional blood supply through monitoring performance and ensuring that operational systems are robust and effective. I helped shape a positive and powerful culture in South Texas Blood & Tissue Center by engaging with and providing ideas and guidance to the team, and always demonstrating and instilling a commitment to donor and patient safety. This role helped prepare me to lead in my next capacity of Chief Operating Officer.

As the Senior Vice President (SVP) at BioBridge Global, I am privileged to play a key role in shaping the strategic direction and overall success of our organization. With a steadfast commitment to advancing the fields of blood and blood components, tissue allografts, and cell/gene therapies, I work alongside a dedicated team to make a meaningful impact on the future of medicine.In my current position, I have the opportunity to drive innovation and collaboration, working with experts and stakeholders to further the mission of BioBridge Global, which is to save and enhance lives through the healing power of human cells and tissues. Our focus on cutting-edge technologies and therapies positions us at the forefront of the healthcare industry.Throughout my career, I've maintained a deep passion for the future of the fields of blood and biotherapies, and I'm excited to be part of an organization that is actively contributing to their development and deployment. BioBridge Global's commitment to excellence and its potential to transform healthcare inspire me daily.

In my role as Vice President of Global Quality & Compliance at BioBridge Global (BBG) from October 2018 to December 2020, I led quality strategy development across BBG and its subsidiaries. My primary focus was on ensuring compliance with internal and external standards while consistently striving to surpass quality benchmarks.Working closely with organizational leaders, I initiated a comprehensive strategy to enhance outcomes and elevate the customer experience in a rapidly expanding global environment. A notable achievement during this time was the establishment of a streamlined customer onboarding framework, which efficiently tracked key milestones and standardized customer integration.During my tenure at BBG, I actively participated in our response to the COVID-19 pandemic. Within the BBG ecosystem, I played a role in launching Community Labs, a pandemic-driven initiative. Community Labs was dedicated to providing cost-effective, highly accurate, and customer-centric PCR tests to schools, businesses, and community sites, with the goal of facilitating the safe return of San Antonians to their daily lives.Throughout the pandemic, Community Labs operated multiple testing sites, conducting over 45,000 PCR tests weekly, with an impressive average turnaround time of less than 10 hours from sample collection to result delivery. We extended our support to local schools, conducting testing on their campuses, and maintained this commitment until March 2023, ultimately administering nearly 2 million tests.As the demand for COVID-19 testing gradually waned due to the successful immunization efforts, I found that this experience reinforced my dedication to leveraging our organization's core capabilities and strengths to explore new avenues in population health. It expanded my perspective on the substantial impact we could achieve.

As the Executive Director of Quality & Compliance at BioBridge Global from October 2017 to October 2018, I had the privilege of leading initiatives to enhance our organization's quality and compliance efforts. During this time, one of my significant accomplishments was the successful implementation of MasterControl, a renowned Quality Management System utilized by hundreds of companies worldwide.MasterControl's quality management system brought automation to our core business processes and document management activities. This implementation not only facilitated collaboration within our organization but also improved decision-making processes and accelerated our time-to-market.In addition to this achievement, I continued to focus on developing and executing strategies to ensure the highest standards of product and service quality while maintaining compliance with internal and external requirements. This experience laid a strong foundation for my subsequent roles, including Vice President of Global Quality & Compliance at BioBridge Global.

As the Senior Director of Quality & Regulatory Affairs at BioBridge Global from July 2016 to October 2017, I was privileged to lead transformative initiatives that significantly improved our quality systems and regulatory compliance across a vast organizational landscape. During my tenure, I championed the integration of risk-based and data-driven decision-making into all quality systems activities, spanning 53 distinct functional areas and numerous global locations. This strategic approach resulted in enhanced operational efficiency and strict adherence to customer and statutory requirements.One of my key achievements during this period was the consolidation of our global infrastructure, bringing together over 70 Quality Unit personnel. By streamlining job types and optimizing resource allocation, we achieved greater effectiveness and resource utilization. Additionally, I spearheaded leadership development programs that improved succession planning, ensuring that our organization continued to thrive with strong, capable leaders.My experiences in this role reinforced the importance of data-driven strategies and risk-based decision-making, which have since been invaluable in my subsequent roles within BioBridge Global. I remain committed to advancing the fields of quality and compliance, driven by a passion for excellence and continuous improvement

As the Director of Quality Assurance at QualTex Laboratories from February 2016 to July 2016, (before transferring within the enterprise to Qualtex’s parent organization) I was entrusted with the responsibility of spearheading improvements in a globally regulated clinical laboratory environment. My focus was on enhancing production and control systems to bolster process efficiency, control, and compliance.Throughout my tenure, I maintained an unwavering commitment to strengthening our organization's dedication to customer satisfaction. This involved prioritizing the timely resolution of quality events and the swift implementation of corrective actions. By doing so, I played a crucial role in driving customer retention through contract renewals.

In my role as Head of Quality Assurance at Bachem, a leading and innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides, from August 2014 to February 2016, I managed the Quality Management Systems (QMS) for Contract Development and Manufacturing Organizations (CDMO), ensuring global regulatory compliance.I oversaw successful facility improvement projects for large-scale active pharmaceutical ingredient (API) production, applying Quality Risk Management (QRM) and Quality by Design (QBD) principles.I also led the assembly of Chemistry Manufacturing and Controls (CMC) content for regulatory filings across multiple regions, maintaining compliance with government regulations, including those of the Department of State and the Drug Enforcement Agency (DEA).About Bachem: Bachem is a prominent and innovation-driven company with expertise in the development and manufacturing of peptides and oligonucleotides. Peptides are short chains of amino acids, often used in various pharmaceutical and biotechnological applications. Oligonucleotides, on the other hand, are short sequences of nucleotides (the building blocks of DNA and RNA) and are vital in genetic research, diagnostics, and therapeutics.As a leader in this field, Bachem is at the forefront of creating these essential biomolecules, playing a crucial role in advancing the pharmaceutical and biotechnology industries. Their dedication to innovation ensures that they remain at the cutting edge of peptide and oligonucleotide science, contributing to the development of new drugs, diagnostics, and research tools that benefit society as a whole.

At StemCyte Cord Blood Bank, I served as the Director of Quality Assurance & Regulatory Compliance. During this role, I directed the strategy for comprehensive changes to the organization's Quality Management System (QMS), fostering improved adoption of GxP standards across all processes.I oversaw clinical programs, collaborating with Principal Investigators to ensure compliance. Additionally, I maintained communication and engagement with various regulatory and accreditation entities, including the FDA, ISO, AABB, FACT, ASHI, CAP, and IRB's/Ethics Committees, both locally and internationally.One of the notable achievements during my tenure was the management and facilitation of multidisciplinary teams for projects, including the design, qualification, and implementation of the world's largest biorepository with a capacity of 160 dewars for Public Cord Blood units.I also played a role in public policy initiatives, contributing to efforts to pass the California Institute of Regenerative Medicine (Prop 71), also known as the California Stem Cell Research and Cures Initiative. This initiative played a pivotal role in bringing significant funding to the industry to advance cures.

As the Manager of Compliance and Quality Assurance at StemCyte, I played a vital role in maintaining and enhancing the organization's commitment to excellence. During my tenure, I focused on several key areas:I led the charge in monitoring our Quality Assurance program, consistently striving to improve performance and uphold the highest standards of quality. This entailed a dedication to revising policies and procedures to align with the ever-evolving landscape of local, state, and federal laws and regulations.One of my significant contributions was strengthening our quality management system and elevating the effectiveness of our Compliance program. I achieved this through the implementation of advanced analysis tools, adept project management, and the application of DMAIC and Six-Sigma methodologies.I brought a data-driven approach to investigations, utilizing Root Cause Analysis and statistical tools and techniques to uncover underlying causes. This approach resulted in a reduction in the number of non-conformance reports as I applied corrective and preventive actions that addressed root causes and systemic issues.My responsibilities extended to overseeing numerous non-conformance reports and FDA reportable events, where I facilitated and monitored the implementation of CAPA (Corrective and Preventive Action) teams.I maintained a vigilant eye on compliance, consistently monitoring non-conformances to identify trends and ensuring thorough investigations and appropriate resolutions.Throughout this role, I provided guidance to multi-disciplinary investigation and implementation teams, utilizing Project Management tools and techniques to streamline processes and drive efficiency.

Responsible for leading Internal Investigations Into compliance gaps and customer service issues, as well as providing regulatory responses to internal/external audits and regulatory Inspection observations and findings.Assembled and facilitated investigation teams to address compliance and regulatory gaps (regulatory remediation activities) to ensure resolution of systemic problems within the organization, resulting in the eventual removal of an FDA Consent Decree of 23 years.Supported numerous device development programs in coordination with medical device manufacturers engaged in pre-market review for therapeutic aphaeresis instruments used for Blood Donors (ALYX Instruments, TRIMA Instruments).

Handling and processing orders of blood products and promptly and efficiently arranging shipment of, and distributed blood products and specimens to different facilities and laboratoriesDirecting the installation of improved work methods and procedures to achieve organizations objectivesProviding thorough supervision for day-to-day operations of facility in accordance with set policies and guidelinesObserving strict confidentiality and safeguarded all donor & patient-related information.