Job Title: Compliance QA Specialist - GxP QualityJob Description The Compliance QA Specialist will play a crucial... role in supporting GxP inspection and audit activities within the inspection readiness program. This includes audit...
of Manufacturing Analyst (Manufacturing data analytics) experience in Life Sciences domain. Collaborate with manufacturing, quality... and implementation comply with regulatory, cybersecurity, and data integrity requirements (21 CFR Part 11, ISO 13485, GxP). Developing...
. Maintain traceable documentation to support GXP activities. Potential opportunity to manage clinical projects. Partner... with key stakeholders including Quality Assurance and Regulatory Affairs to ensure supplies are labeled and released...
timely delivery of high-quality Microsoft 365 applications. Coordinate with vendors and service providers to support..., business, and IT teams to support effective execution and issue resolution. Operational Excellence, Quality & Compliance...
risks. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business... across the GxP landscape that identifies and manages issues and risks while driving continuous improvement to ensure continuous...
performance. Establish and enforce data governance policies, data quality standards, security protocols, and compliance... frameworks (e.g., FAIR, GxP, HIPAA, IAM, Data Mesh). Implement and manage AWS Lake Formation and Databricks Unity Catalog...
., GxP, HIPAA, GDPR) and internal quality and security standards. Ensure that all product releases meet rigorous quality... objectives. Partner with engineering, architecture, and quality assurance teams to ensure timely delivery of secure, scalable...
regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality standards. Ownership to quality assurance activities... timely delivery of high-quality digital applications. Own the coordination with vendors and service providers to support...
and processes meet regulatory and internal standards (e.g., GxP, HIPAA, GDPR). Ownership to quality assurance activities to help... to support the delivery of secure, scalable, and high-quality digital applications. Own the coordination with vendors...
regulatory requirements (e.g., GxP, HIPAA, GDPR, SOX) and internal quality and security standards. Ensure that all product... functions. Partner at a strategic level with engineering, architecture, and quality leaders to ensure the delivery of secure...