What are the responsibilities and job description for the Life Science QA Test Program Manager position at Cognizant Technology Solutions?
Cognizant Technology Solutions is currently seeking a highly skilled Life Science QA Test Program Manager who will be responsible for managing the project delivery of Pharma Testing & Validation engagement.
Are you ready to be a change-maker? At Cognizant, we believe those who challenge the way they work today will lead the way tomorrow!
Ability to work independently and remotely, with willingness travel for client engagements as needed.
Responsibilities :
- Develop and implement comprehensive Validation and Test strategies aligned with regulatory requirements such as FDA, EMA, and GxP standards, supporting the transition to CSA.
- Identify new areas for penetration, partner with key stakeholders to showcase the testing and validation capabilities of various solutions across pharm domain, and develop plans to move these initiatives forward
- Define objectives and priorities for Validation and testing activities across clinical, regulatory, and manufacturing systems, focusing on digital transformation and paperless execution.
- Collaborate with project stakeholders, including regulatory and compliance teams, to establish Validation and testing protocols and ensure adherence to CSV / CSA principles.
- Define strategy and support transitioning from paper-based to ALM / Test management tool in compliance with regulatory requirements.
- Manage end-to-end Validation and test phases for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation.
- Ensure compliance with industry regulations, including 21 CFR Part 11, focusing on Good Automated Manufacturing Practices (GAMP).
- Lead risk-based Validation and testing efforts to mitigate compliance risks across applications
- Define standard to Design and execute Validation and test scripts that confirm systems meet GxP and CSV / CSA standards, ensuring they are audit-ready.
- Define standards to maintain detailed documentation of test results, issues, and resolutions to support regulatory audits and digital transition inspections.
- Identify opportunities for Test automation and work with Architects and Automation specialist to implement
- Ensure adoption of automated testing tools and frameworks suitable for pharmaceutical applications, ensuring they meet validation and CSA requirements.
- Continuously review and refine testing processes, contributing to improved productivity, quality, and compliance with digital initiatives.
- Act as the primary liaison between QA, regulatory, and business teams, providing regular updates on testing progress & outcomes
- Prepare comprehensive reports on Validation and testing activities, including transformation progress.
- Lead regular meetings with stakeholders to discuss Validation and testing plans, CSA outcomes, and opportunities for continuous improvement.
Required Skills / Qualifications :
Home office setup (network, phone, etc.) Our strength is built on our ability to work together. Our diverse backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our clients. We want someone who thrives in this setting and is inspired to craft meaningful solutions through true collaboration.
If you are comfortable with ambiguity, excited by change, and excel through autonomy, we'd love to hear from you.
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