Quality Assurance Leader - Clinical-Stage Manufacturing Oversight

Anna K Spann

Greater Houston Area LinkedIn 832-***-**** **********@*****.***

SUMMARY

● Led quality oversight activities across 5 CDMOs supporting clinical-stage manufacturing operations.

● Trained and qualified 50+ analysts across multiple US and international sites.

● Served as primary analytical quality liaison between Technical Operations, QA, Manufacturing, Supply Chain, and 7 external partners.

● Provided on-call quality oversight for 5+ clinical manufacturing campaigns per month, performing real-time assessment and resolution of QC testing issues, deviations, and out-of-specification results to support manufacturing continuity and batch release while maintaining GMP compliance and product quality.

● Represented quality control organization as potency assay subject matter expert during 2 FDA inspections, responding to inquiries regarding assay execution, deviation management, out-of-specifications and GMP compliance practices. WORK EXPERIENCE

Galapagos NV Remote, USA

Senior Scientist, Quality October 2024 - Present

● Lead analytical Quality Control oversight for outsourced testing operations across a multi-site U.S. CDMO network supporting clinical-stage cell therapy programs, ensuring readiness for manufacturing, release, stability, and development milestones.

● Travel 30–40% to partner sites to provide hands-on technical oversight, analyst training, troubleshooting, and on-site support during method transfers, assay implementation, and time-sensitive clinical manufacturing runs.

● Execute international knowledge transfer initiatives by training at headquarters in Leiden, Netherlands on core analytical methods and operational processes, then deploying assays and training teams across U.S. CDMO sites.

● Operate as primary QC liaison between internal stakeholders and external partners, resolving complex analytical, compliance, scheduling, and execution issues while aligning Technical Operations, QA, Supply Chain, and Manufacturing teams.

● Manage deviation investigations, quality events, CAPA execution, and technical assessments while reviewing protocols, reports, and GMP records to support compliance, inspection readiness, and operational continuity across a multi-site manufacturing network. Bristol Myers Squibb Bothell, WA

Scientist, Quality Control & Quality Training April 2021 - October 2024

● Served as subject matter expert for 8+ analytical methods supporting GMP release and in-process testing across global cell therapy operations.

● Trained 50+ analysts globally across U.S., EU, and APAC sites to support harmonized QC execution, method consistency, and GMP-aligned documentation practices.

● Developed scalable training systems including SOPs, technical curricula and SCORM modules

● Collaborated with site QC leaders to harmonize analytical practices, documentation standards, and training consistency globally.

● Supported regulatory inspections and audit readiness activities, responding to documentation and compliance requests.

● Conducted instructor-led classroom training for QC personnel on GDocP, safety procedures, site evacuation routes, and emergency response plans.

KBI Biopharma The Woodlands, TX

Senior Bioassay Analyst, Quality Control May 2020 - April 2021

● Performed GMP-compliant analytical testing for clinical-stage client programs, including cell-based potency, cytotoxicity, and release-support bioassays in a regulated CDMO environment.

● Executed time-sensitive QC testing to support batch disposition, manufacturing timelines, and client deliverables across multiple concurrent programs.

● Resolved assay performance issues and partnered with laboratory leadership to maintain data quality, schedule adherence, and compliant execution.

● Authored and revised SOPs, test methods, and controlled documents to improve assay robustness, efficiency, and GMP alignment.

● Supported analyst onboarding and peer training to strengthen laboratory consistency, technical capability, and right-first-time performance

Bellicum Pharmaceuticals Houston, TX

Senior Research Associate, Assay Development and Quality Control October 2018 - May 2020

● Supported analytical development and Quality Control activities for clinical-stage CAR-T cell therapy programs within a fast-paced biotechnology environment.

● Executed analytical method transfers between Assay Development, Quality Control, and external testing organizations to enable phase-appropriate GMP testing readiness.

● Performed potency and functional bioassays, including AlphaLISA-based testing, to support product characterization, release readiness, and process development initiatives.

● Authored and revised SOPs, test methods, and technical documentation in partnership with Quality Assurance to strengthen compliance and assay lifecycle control. MilliporeSigma The Woodlands, TX

Senior Manufacturing Associate January 2014 - March 2017

● Manufactured GMP oligonucleotide products in a regulated production environment, adhering to batch records, SOPs, and quality system requirements.

● Performed aseptic fill-finish operations and supported controlled processing activities requiring strict compliance with safety and contamination control standards.

● Partnered with Engineering, Validation, and Quality teams during equipment installation, qualification, and process readiness initiatives.

● Trained new personnel on GMP documentation practices, operational procedures, and workplace safety expectations.

EDUCATION

University of Washington Seattle, WA

Master of Science, Pharmaceutical Bioengineering May 2025 University of Houston Houston, TX

Bachelor of Science, Interdisciplinary Studies, Biology Concentration December 2013

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