Cambridge, MA | Contract
The role of Validation/SDLC lead provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices. This is accomplished by
• Participating in the delivery of system solutions by documenting SDLC/CSV/Qualification activities.
• Developing validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
• Executing validation/qualification/verification/migration strategies per company procedure(s).
• Providing validation/verification/qualification training to stake holders as necessary.
• Managing relationships with key customers and stake holders to ensure the total validation/verification/qualification solution delivered to the customer meets/exceeds expectations.
• Working with off shore team/testers.
• Ensuring SDLC/CSV/Qualification activities are conducted in a cost-effective manner.
• Subject Matter Expert on client’ s SDLC/Qualification procedure and able to provide guidance to IT and/or Business.
• Participate on cross functional teams to validate/verify, implement, and maintain regulated (Example: GxP, JSOX etc.) and/or non-regulated systems across.
• Lead the validation/verification/qualification strategy by either working with the offshore testers to develop the test strategy or develop the strategy, then obtaining approval from the business and/or IT.
• Work with project team’ s offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
• Ensure the project testing timeline is met per specified agreement and/or scope change.
• Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
• Thoroughly understands the difference between Positive versus Negative Testing.
• Support testing in either an IT or Business area, ensuring compliance with all company and departmental policies, procedures and standards
Analyze test results and ensure requirement objectives and documentation standards have been met.
Insure all SDLC deliverables are completed and have stored appropriately
• Leads resolution efforts when issues are identified and escalate appropriately.
• Actively share emerging industry standards/trends with customers and peers within area of responsibility
• Support the response and remediation of corrective actions and internal audits
• Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks
• Proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant