Karen Tyburski

About Karen Tyburski

Detail-oriented and process-driven Quality professional with extensive experience across Quality Systems, Quality Assurance, Quality Control, Computer System Validation (CSV), Data Integrity, Third-Party Management, and Compliance. Adept at designing, implementing, and monitoring Quality Systems under Consent Decree conditions, with a strong track record of driving regulatory alignment and operational excellence.Expert in Quality Third Party (QTP) Management, including QMS integration, program oversight, qualification processes, post-market commitments, ISO 13485 compliance for combination products, supplier change notifications, QTP alerts, and KPI development. Delivered strategic quality oversight for high-impact Third-Party Partnerships, supporting regulatory submissions and managing transitions to partner-controlled Contract Manufacturing Organizations (CMOs) for Drug Product and packaging operations.Provided compliance oversight for cGMP API Biologic facilities as a key member of the Site Consent Decree Monitoring Team. Recognized for strategic leadership in matrixed environments—able to influence without authority, foster collaborative relationships, and consistently meet project milestones. Proven success both as a team leader and individual contributor, with a reputation for integrity, precision, and cross-functional impact.

Experience

1. Associate Director Qa - Quality Systems and Compliance

   GSK

   Aug 2023 — Present · Cambridge, MA, US

   Spearheaded the integration of GSK and regulatory standards at the Binney Street GMP Manufacturing site (clinical to commercial), ensuring compliance and product quality. • Manage the Quality Management System (QMS), focusing on Deviation, CAPA, Change Control, Documentation, Training, Quality Risk Management, Quality Review and Audits to maintain inspection readiness. • Established an efficient QA Document Control and Archival function, significantly improving documentation processes and compliance adherence.

Education

• Northeastern University

  B.S., Biological Sciences

Skills

• Corrective and Preventive Action (Capa)
• Gmp
• Life Sciences
• Calibration
• Quality System Remediation
• Standard Operating Procedure (Sop)
• Qc
• Biotechnology
• Change Control
• Medical Devices
• Capa
• U.s. Title 21 Cfr Part 11 Regulation
• Trackwise
• Qsr
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• 21 Cfr Part 11
• Governance Structure
• Computer System Validation
• Biopharmaceuticals
• Cgmp
• Consent Decree Remediation
• Quality Auditing
• Cross-Functional Team Leadership
• Root Cause Analysis
• Compliance
• Validation
• U.s. Food and Drug Administration (Fda)
• Quality System
• Quality Systems
• Document Management
• Pharmaceuticals
• Regulatory Requirements
• Quality Assurance
• Software Validation
• Quality Management
• Gamp