Life Science QA Test Program Manager - Associate Director

Company: Cognizant
Location: Chicago
Posted on: November 15, 2024

Job Description:

Cognizant Technology Solutions is currently seeking a highly skilled Test Program Manager - Life Science 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:
• 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.
• CSV/CSA Expertise: In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.
• Knowledge on ALM Test management tool.
• Regulatory Knowledge: Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements; experience with GAMP and validation processes.
• Automation: Exposure to test automation frameworks.
• Project Management: Solid project management skills, with the ability to manage complex test programs, resource allocation, and timelines.
• Cross-Functional Collaboration: Demonstrated success in working with diverse teams, including QA, regulatory, and business stakeholders, to achieve shared goals.
• Communication & Reporting: Excellent written and verbal communication skills, including the ability to prepare clear reports and conduct stakeholder meetings effectively.
• Education: Bachelor's degree in computer science, Life Sciences, or a related field; advanced degree preferred.
• Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. If you are comfortable with ambiguity, excited by change, and excel through autonomy, we'd love to hear from you.
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Keywords: Cognizant, Janesville , Life Science QA Test Program Manager - Associate Director, Executive , Chicago, Wisconsin