Katalyst CRO

Validation Lead

about 1 month ago

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Roles & Responsibilities

Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery.
Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes.
Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting.
Expertise in Client ALM for managing testing cycles, with broad technical knowledge of SaaS and Cloud systems in a GxP environment.
Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing.
Flexibility to work across time zones, manage multiple projects, and travel as needed, with Life Sciences or Pharma experience preferred.

Requirements:

Experience and education in Life Sciences or Pharma preferred.
Testing/Validation for System Implementations.
Knowledge and prior experience in testing and validation for medium to large system implementations.
Experience in working with SaaS and Cloud systems in a GxP environment.
Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines.
Proficiency with Client ALM (Application Lifecycle Management).
Experience with Waterfall, Iterative, and Agile methodologies.
Industry-specific Experience.
Adaptability: Ability to quickly adjust to new technologies, workflows, and environments.
Communication: Excellent communication skills, both verbal and written.
Flexibility to work in different time zone hours and travel as required.