Tara Crnkovich
ELLICOTT CITY,MD
Summary
Biopharma executive with 25+ years turning strategy into execution across multi-site cGMP manufacturing, quality, and compliance operations. Known for building organizations that perform under pressure — integrating functions, designing governance, and delivering measurable results in Cell & Gene Therapy, Biologics, and regulated manufacturing environments. The leader organizations call when complexity is high and execution has to be flawless.
Overview
2027
2027
years of professional experience
1
1
Certification
Work History
Head of QA Operations
Arcellx
Rockville, Maryland
12.2022 - Current
- Own end-to-end quality governance across multi-site cGMP network and contract partners, ensuring alignment with enterprise transformation priorities and regulatory standards
- Established and chaired executive governance bodies (Quality Management & Risk Review Committee, Material Review Board) to enhance leadership visibility and cross-site coordination.
- Achieved 20% reduction in production deviation cycle time and 30% improvement in deviation closure rates by launching a Phase-Appropriate Quality System Framework.
- Reduced supplier quality deviations by 15% through optimized external partner performance management
- Built and monitored executive dashboards for on-time lot release, supplier quality, and program health; translated data insights into actionable improvement roadmaps.
- Stabilized execution of complex multi-team cGMP manufacturing capability build-out by implementing structured planning, workstream tracking, and executive reporting.
- Mentored and developed high-performing QA team; standardized best practices to support long-term delivery capability in a high-growth, matrixed biotech environment.
Sr. Director, Manufacturing Sciences - Site Lead
AstraZeneca
Gaithersburg, MD
06.2021 - 12.2022
- Directed operations for dual cGMP manufacturing facilities (Cell & Gene Therapy and Clinical Biologics Drug Substance), establishing quality strategies and production schedules that ensured compliance and operational efficiency.
- Pioneered design and implementation of operational capabilities for clinical production at AstraZeneca's cGMP Cell and Gene Therapy Manufacturing Facility, enhancing production readiness and regulatory alignment.
- Achieved 20% reduction in production deviation cycle time through lean manufacturing practices and embedding quality into daily operations.
- Configured and implemented a digital supply chain orchestration platform for cell and gene therapy products, enabling enterprise-scale transformation and improving product delivery timelines.
Associate Director, Manufacturing Sciences
AstraZeneca
Gaithersburg, MD
2017 - 2021
- Integrated four key functions into a high-performing, delivery-focused organization, enhancing governance and accountability across Manufacturing Sciences.
- Delivered 25+ validation projects in Q4 2019 alone by developing a new Site Validation resource model and hiring strategically to build surge capacity.
- Achieved 30% improvement in validation cycle times under a unified execution framework in under 6 months.
- Developed resource and staffing strategy to enable surge capacity coverage across three biomanufacturing facilities, ensuring operational readiness.
- Directed technical writing, New Product Introduction documentation, investigations/CAPAs, change controls, and risk assessments for clinical programs, ensuring compliance and quality.
Senior Manager, Manufacturing Sciences
AstraZeneca (Formerly MedImmune)
Gaithersburg, MD
2011 - 2017
- Increased operational efficiency by 20% by leading risk assessments enabling production at two new biomanufacturing plants, including a complex facility changeover between viral and mammalian cell culture manufacturing.
- Launched Manufacturing Sciences Rotation Program to enhance leadership capability and workforce agility across sites.
- Established R&D GMP Learning Council to synchronize training, development, and compliance initiatives with site and corporate objectives.
- Managed integration of new cGMP biomanufacturing plant, including validation, non-conformance, CAPA, change control, metrology, maintenance, and documentation systems.
Quality Assurance Manager / Validation Manager
AstraZeneca (Formerly MedImmune)
Gaithersburg, MD
2007 - 2011
- Led validation and startup activities as QA Technical Lead, facilitating successful operations for two distinct cGMP manufacturing sites
- Developed and oversaw integrated commissioning and qualification program, ensuring compliance and consistency across multiple sites
- Led site preparation for cGMP inspections, effectively hosting annual Corporate Compliance and partner inspections
- Implemented a Quality on the Floor (OTF) program improving manufacturing changeover turnaround time by 15%; led OTF Team operations across two cGMP production facilities
Validation Manager
CoGenesys
Rockville, MD
2006 - 2007
QA Change Control/Technical Services Specialist
Wyeth Biotech
Sanford, NC
2003 - 2006
Validation Specialist
CRB Consulting Engineers
Cary, NC
2002 - 2003
Validation Specialist
O'Neal Engineering
Morrisville, NC
2000 - 2022
Education
Master of Science - Biotechnology
University of Maryland
MD01-2006
Bachelor of Science - Human Nutrition
West Virginia University
Morgantown, WV01-1999
Skills
- Quality Systems & Regulatory Readiness
- Multi-Site GMP Operations
- Cell & Gene Therapy Manufacturing
- Tech Transfer & Validation
- Risk Assessment and Governance
- KPI Development & Data Visualization
- Lean/Continuous Improvement
- Digital Platform Rollout
- Change Management
- Portfolio Planning & Execution
- Cross-Functional Collaboration
- Talent Development
- Executive Communication
Certification
Villanova University - Organizational Development, 2019
Key Achievement Highlights
- Enterprise Transformation: Stabilized multi-team cGMP capability build-out with structured planning & executive reportingImproved leadership visibility & delivery coordination — ArcellxExecution
- Governance: Delivered 25+ validation projects under unified framework in <6 months30% cycle-time improvement — AstraZeneca
- Lean Operations: Embedded lean practices into deviation management20% reduction in deviation cycle time — AstraZeneca & Arcellx
- Digital Transformation: Selected & implemented digital supply chain platform for CGT products accelerated supply readiness — AstraZeneca
- External Partner Optimization: Redesigned supplier performance management15% reduction in quality deviations — Arcellx
- Capability Building: Launched Phase-Appropriate Quality System Framework20–30% deviation closure improvement — Arcellx & AstraZeneca
- Workforce Development: Founded Manufacturing Sciences Rotation Program & R&D GMP Learning Council and sustained pipeline of leadership talent — MedImmune
Timeline
Head of QA Operations
Arcellx
12.2022 - Current
Sr. Director, Manufacturing Sciences - Site Lead
AstraZeneca
06.2021 - 12.2022
Associate Director, Manufacturing Sciences
AstraZeneca
2017 - 2021
Senior Manager, Manufacturing Sciences
AstraZeneca (Formerly MedImmune)
2011 - 2017
Quality Assurance Manager / Validation Manager
AstraZeneca (Formerly MedImmune)
2007 - 2011
Validation Manager
CoGenesys
2006 - 2007
QA Change Control/Technical Services Specialist
Wyeth Biotech
2003 - 2006
Validation Specialist
CRB Consulting Engineers
2002 - 2003
Validation Specialist
O'Neal Engineering
2000 - 2022
Master of Science - Biotechnology
University of Maryland
Bachelor of Science - Human Nutrition
West Virginia University