Cognizant North America
Life Science QA Test Program Manager - Associate Director
Cognizant North America, Boston, Massachusetts, us, 02298
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 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.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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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 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.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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