Judith Svarczkopf

About Judith Svarczkopf

A spirited teacher, who, by recognizing the inherent good and beauty in others, can inspire, motivate and guide teams of diversely talented individuals to be open to the possibility of what may unfold and who invites them to be fully engaged in that co-creation.An authentic and effective leader – strategic, transformational; yet, pragmatic on business and caring and compassionate about people. Energetic organizer and facilitator, who can guide teams to achieve timely completion of goals. Able to synthesize inputs from a variety of sources into an organized and comprehensive plan, working at both the detail and visionary levels. Innovative and resourceful problem-solver capable of managing multiple priorities and performing under pressure in a fast-paced, rapidly changing environment.Biochemical Engineer by education; leader by experience; a Certified Project Management Professional (PMP) and Six Sigma Black Belt. Extensive experience within biotechnology and medical device industries, with a focus on combination and more recently in cell and gene therapy products. Exceptional blend of Project Management, Team Leadership, Scientific Expertise, and worldwide Regulatory and Quality focused on entire product life cycle. Reputation for robust strategy development utilizing risk management principals.Specialties:• Combination Products and Medical Devices• Conflict Resolution• Design & Process Verification/Validation• Global Product Launches• Life Cycle Management• Portfolio Management• QA and Regulatory Compliance• Quality Systems Governance• Reducing Costs• Regulatory Submissions (US/Europe)• Risk Management• Six Sigma Process Excellence• Supply Chain Continuity

Experience

1. Principal Quality Assurance Manager (Equivalent to Associate Director), Cell & Gene Therapy Quality

   Genentech

   Sep 2021 — Present · South San Francisco, CA, US

   Individualized Therapies Quality Systems Lead for the Biospecimen, Genomics and Bioinformatics (GB2) portion of individualized cell and gene therapies. Provide expertise and guidance to develop, implement and execute on a novel quality framework focusing on the neoantigen selection process for individualized neoantigen specific therapy programs. Quality Assurance operational support for multiple individualized therapy products, including selection and quality oversight of CDMOs for biospecimen processing and analysis; genomics assay development and implementation; bioinformatic pipeline development and implementation in the cloud.

Education

• University of Tennessee, Knoxville

  MS, Child Development, option in Special Education

• Purdue University

  MS, Engineering

• Rutgers University

  Bachelor of Science - BS, Chemical Engineering, option in Biochemical Engineering

Skills

• Fmea
• Technology Transfer
• Drug Delivery
• Validation
• Clinical Trials
• Cross-Functional Team Leadership
• Biopharmaceuticals
• Pharmaceutical Industry
• Fda
• Six Sigma
• Product Launch
• Regulatory Submissions
• Process Improvement
• 21 Cfr Part 11
• Pharmaceutics
• Project Management
• Medical Devices
• Quality Assurance
• Biotechnology
• Gmp
• Quality System
• Product Lifecycle Management
• V&V
• Change Control