System Assurance Lead

Requirement/Must Have:

• 10+ years of experience in validating systems and performing CSV activities in GxP-related applications such as LIMS, custom applications, AI, and innovative tools.
• Strong experience with Computer System Validation and Computer System Assurance.
• Proficiency in GAMP, GxP risk assessments, change management, communication, and organization.
• Working knowledge of end-to-end validation of GxP applications and ability to perform document process compliance analysis.
• Adept with Agile and Waterfall methodology based software development compliance.
• Experience in CSV using Agile methodology.
• Ability to review requirement specifications, functional specifications, user stories, and acceptance criteria.
• Ensures test scripts are complete with proper traceability.
• Ensures risk assessments are completed for all requirements and test cases are designed based on identified risk levels.
• Performs review of pre-executed test protocols, ensuring completeness and appropriateness of test cases.
• Ensures test data requirements are captured in pre-executed test protocols.
• Reviews post-executed test protocols for completeness, accuracy, and supporting evidence.
• Provides guidance on defect management processes.
• Able to author validation plans and compile validation summary reports.
• Generates RTMs and ensures operational procedures for applications are ready.
• Able to handle change requirements for small implementations, including implementation plans, impact assessments, test plans/results, defects, and RTMs.
• Prior experience using tools such as ALM, DMS, and JIRA.
• Good to have experience in implementing US-DSCSA.

• Serve as the single point of contact for geo-specific and function-specific system assurance and compliance scope, including CSA, validation SME, and test management.
• Responsible for service quality, performance, customer satisfaction, and demand management within assigned regions or functions.
• Perform CSL roles such as CSA, Validation SME, and Test Manager as required by CSL QMS.
• Build and manage relationships with regional stakeholders, including gathering and resolving feedback.
• Review system assurance and compliance deliverables and provide daily guidance to the team.

• Primary: Computer System Validation, Computer System Assurance, GAMP, GxP risk assessments, change management, communication, organization.
• Secondary: JIRA, Veeva, Agile, Waterfall methodology.