Dawn Farrell
Director, External Quality Assurance at Arvinas, Inc.
- Role
- Director, External Quality Assurance at Arvinas Inc at Arvinas
- Location
- New Haven, CT, US
- LinkedIn followers
- 500 followers
About Dawn Farrell
Experienced, dedicated, value driven and technically skilled Quality Assurance professional with 25+ years of cGxP experience in the biotech/pharmaceutical field. Professional Skills:CDMO Management, cGMP Compliance, Regulatory Compliance, Quality Agreement, Quality Control, Deviation/Investigation/CAPA, Change Management, Data Integrity, Method Validation, Method Transfer, Project Management, Batch Review, Batch Disposition, Root Cause Analysis, Product Development Collaboration, Quality Assurance Metrics and KPIs, Problem-Solving Skills, Strategic Planning and Execution, IND, IMPD, CTA Verification, Veeva Vault & TrackWise Quality Management System.1. Interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.2. Participates in cross-functional project teams and drives team performance and results. Routinely recognizes and resolves Quality issues.4. Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions.5. Drives continuous improvement and improves efficiency and productivity within the group or project.6. Critically assesses project(s) and allocates resources to efficiently achieve goals. Effectively communicates internally within the function and with internal and external cross-functional teams8. Manages conflict and issues with internal and external customers. Oversees Batch Review, Analytical Review, and Regulatory Review.
Experience
Director, External Quality Assurance at Arvinas Inc
May 2025 — Present
Education
University of New Haven
Bachelor of Science - BS, Forensic Science and Technology
University of New Haven
Bachelor of Science (BS), Chemistry
Skills
- Lims
- Cgmp Practices
- V&V
- Trackwise
- Technology Transfer
- Regulatory Submissions
- Change Control
- Clinical Development
- Capa
- Gmp
- Hplc
- Gcp
- Biopharmaceuticals
- Computer System Validation
- 21 Cfr Part 11
- Biotechnology
- Gxp
- Quality Assurance
- Validation
- Glp
- Regulatory Affairs
- Pharmaceutical Industry
- Sop
- Fda
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