Life Science QA Test Program Manager - Associate Director

Cognizant Technology Solutions - Chicago, IL

Full-time - Senior

Chicago, IL

10,001+ employees

Professional, Scientific, and Technical Services

About the position

The Life Science QA Test Program Manager Associate Director at Cognizant Technology Solutions is responsible for overseeing the project delivery of Pharma Testing & Validation engagements. This role involves developing and implementing validation and testing strategies that comply with regulatory requirements, managing end-to-end validation phases, and ensuring adherence to industry standards. The position requires strong leadership skills, extensive experience in the pharmaceutical domain, and the ability to collaborate with various stakeholders to drive digital transformation initiatives.

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 the pharma 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 standards 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 specialists 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.

Requirements

• 15+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and 5+ years in a management role.
• In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.
• Knowledge on ALM Test management tool.
• Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements; experience with GAMP and validation processes.
• Exposure to test automation frameworks.
• Solid project management skills, with the ability to manage complex test programs, resource allocation, and timelines.
• Demonstrated success in working with diverse teams, including QA, regulatory, and business stakeholders, to achieve shared goals.
• Excellent written and verbal communication skills, including the ability to prepare clear reports and conduct stakeholder meetings effectively.
• Bachelor's degree in computer science, Life Sciences, or a related field; advanced degree preferred.

Nice-to-haves

• ISTQB, PMP, or relevant regulatory compliance certifications.

Benefits

• Home office setup (network, phone, etc.)
• Collaborative and inclusive workplace environment
• Opportunities for career growth and development