Carla Cooper

Clinical operations, cell therapy, and program management leader with 15+ years of experience leading multi-site operations, apheresis programs, donor-derived biologics, quality systems, compliance initiatives, and cross-functional healthcare operations. Proven track record building national collection programs, improving operational quality, reducing deviations, and supporting regulated clinical and cellular therapy environments.

Senior Clinical Operations & Program Manager (Apheresis & Cell Therapy) at GRIFOLS Bio Supplies (2022-05 – 2024-09)

Directed national apheresis program operations across five sites for donor-derived biologics and apheresis-based clinical material, supporting early-stage and translational research programs.

• Led cross-functional coordination across clinical sites, manufacturing partners, logistics teams, and regulatory/quality groups to ensure timely, compliant delivery of cellular starting material.
• Developed program plans, timelines, risk registers, and operational frameworks to support high-stakes, multi-site workflows.
• Strengthened chain-of-identity and chain-of-custody processes, reducing operational risk and improving audit readiness.
• Oversaw vendor and CRO partnerships, including performance oversight, contract alignment, and issue escalation.
• Partnered with clinical, quality, and regulatory teams to ensure GCP/GTP compliance and operational readiness.
• Implemented site qualification, onboarding, and training frameworks for new apheresis centers.
• Implemented CAPA and deviation-reduction initiatives that decreased operational deviations by 75% across participating sites.
• Served as the primary operational liaison for internal and external stakeholders, ensuring alignment on program goals, milestones, and deliverables.

Clinical Quality & Operations Manager at American Red Cross (2019-09 – 2021-12)

Led quality, compliance, and operational oversight for multi-site clinical and donor-collection programs.

• Managed IRB submissions, protocol adherence, and regulatory documentation across high-volume clinical environments.
• Conducted root-cause investigations, developed CAPAs, and improved documentation quality and operational consistency.
• Oversaw vendor performance, contract adherence, and operational governance.
• Managed inspection readiness, documentation quality, and regulatory compliance.
• Supported implementation of CTMS, IRT, EMR, and quality systems (Veeva, TrackWise, Salesforce).
• Designed and delivered training programs to strengthen competency, reduce errors, and support inspection readiness.
• Partnered with cross-functional teams to align operational workflows with FDA, AABB, and HIPAA requirements.

Clinical Operations & Program Supervisor at American Red Cross (2012-09 – 2019-09)

Managed daily operations, staffing, scheduling, and performance for donor services and clinical support teams.

• Oversaw multi-site workflows, ensuring service quality, regulatory compliance, and operational continuity.
• Implemented process improvements that increased productivity and reduced operational bottlenecks.
• Supported disaster response and emergency operations, coordinating cross-functional teams under high-pressure conditions.

Clinical Operations Supervisor at American Red Cross

Senior Associate Problem Manager/Quality Associate at American Red Cross

Blood Collection Team Supervisor at American Red Cross

Associate Problem Manager/Quality Associate at American Red Cross

Bachelor of Science in Health Administration & Management – University of Phoenix (2012)

Diploma in Medical Assisting – Remington College