Cognizant
Validation Lead(ALM) : QA Life Sciences(Hybrid)
Interested in this role You can find all the relevant information in the description below. Cognizant Technology Solutions is seeking a Validation Lead(ALM) : QA Life Sciences(Hybrid) to join our team in a permanent role. This opportunity targets candidates with a strong background in Testing & Validation within the pharmaceutical or life sciences domain, including regulatory and digital transformation experience.
About Cognizant’s QEA Practice:
We are the largest Quality Assurance Practice globally servicing 800+ clients. We provide Next Gen QA offerings such as System Modernization Assurance, Business Process Assurance, Quality Engineering, Cloud Platform Assurance, Customer Experience Assurance, and Robotic Test Automation. We have been ranked #1 for Market Impact by Everest Group for four consecutive years and #1 for completeness of vision, test advisory, and Digital Business Assurance in Gartner Magic Quadrant.
Onsite Location : Foster City, CA
Qualifications
10+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and 2+ years in a management role.
CSV/CSA Expertise: In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.
Knowledge of 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.
Experience in Salesforce Implementation and Testing (Nice to have).
Experience in managing Data Testing (Nice to have) – includes ETL Testing, Data Warehouse Testing, Data Lakes, Hadoop, Data Transformation, Data Sampling techniques.
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 QA, regulatory, and business stakeholders.
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.
Roles & 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 testing and validation capabilities 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 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.
Work Authorization
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship (H-1B, L-1B, L-1A, etc.).
Salary and Other Compensation
Applications will be accepted until 9/8/2025.
The annual salary for this position is between $71,100 and $112,500, depending on experience and other qualifications of the successful candidate.
This position is eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
Benefits
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
#J-18808-Ljbffr Remote working/work at home options are available for this role.
Interested in this role You can find all the relevant information in the description below. Cognizant Technology Solutions is seeking a Validation Lead(ALM) : QA Life Sciences(Hybrid) to join our team in a permanent role. This opportunity targets candidates with a strong background in Testing & Validation within the pharmaceutical or life sciences domain, including regulatory and digital transformation experience.
About Cognizant’s QEA Practice:
We are the largest Quality Assurance Practice globally servicing 800+ clients. We provide Next Gen QA offerings such as System Modernization Assurance, Business Process Assurance, Quality Engineering, Cloud Platform Assurance, Customer Experience Assurance, and Robotic Test Automation. We have been ranked #1 for Market Impact by Everest Group for four consecutive years and #1 for completeness of vision, test advisory, and Digital Business Assurance in Gartner Magic Quadrant.
Onsite Location : Foster City, CA
Qualifications
10+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and 2+ years in a management role.
CSV/CSA Expertise: In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.
Knowledge of 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.
Experience in Salesforce Implementation and Testing (Nice to have).
Experience in managing Data Testing (Nice to have) – includes ETL Testing, Data Warehouse Testing, Data Lakes, Hadoop, Data Transformation, Data Sampling techniques.
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 QA, regulatory, and business stakeholders.
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.
Roles & 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 testing and validation capabilities 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 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.
Work Authorization
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship (H-1B, L-1B, L-1A, etc.).
Salary and Other Compensation
Applications will be accepted until 9/8/2025.
The annual salary for this position is between $71,100 and $112,500, depending on experience and other qualifications of the successful candidate.
This position is eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
Benefits
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
#J-18808-Ljbffr Remote working/work at home options are available for this role.