Cognizant
Overview
Cognizant Technology Solutions is looking for “ Validation Lead (GxP & Life Sciences Domain) ” to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you! About Cognizant’s QEA Practice We are the largest Quality Assurance Practice Globally servicing 800+ Clients. We bring the industry leading vision and expertise to help with Quality Engineering transformation journey for our reputed clients. We provide Next Gen QA offerings like 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 times in a row and ranked #1 for completeness of vision, test advisory and Digital Business Assurance in Gartner Magic Quadrant! Role Location : Boston, MA (Remote) Required Qualifications
Deep Knowledge of GxP Regulations Strong understanding of FDA, EMA, MHRA, and other global regulatory requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5). Validation Lifecycle Expertise Proficiency in managing the full validation lifecycle: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports. Strong Documentation and Audit Readiness Skills Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. Proven track record in preparing for internal and external audits Life Sciences Domain Expertise Familiarity with pharmaceutical industry Strong experience in manufacturing domain and systems like OPM, Informatica, Veeva QMS & DMS, ARVETO 3PL, Oracle Transportation, Global Trade Management, Oracle EBS Leadership and Stakeholder Management Ability to lead cross-functional teams and coordinate with QA, IT, and business stakeholders. Skilled in managing validation deliverables across geographies and time zones Risk-Based Validation and Process Optimization Experience in risk assessment, deviation handling, CAPA management, and process harmonization. Familiarity with Agile, Waterfall, and V-Model SDLC approaches Technical Proficiency and Tool Familiarity Proficient in tools like HP ALM, JIRA, ServiceNow, SharePoint Comfortable with data validation, integration testing, and analytics platforms Responsibilities
Lead the testing strategy for Document Management Systems, ensuring robust and efficient processes. Oversee interoperability validation to guarantee seamless integration across platforms. Coordinate CSV activities to ensure compliance with regulatory standards. Utilize ALM tools to manage and streamline testing workflows. Collaborate with research and development teams to align testing with project goals. Develop comprehensive test plans and cases to cover all functional and non-functional requirements. Monitor and report on testing progress, identifying, and addressing any issues promptly. Ensure all testing activities adhere to company policies and industry best practices. Mentor and guide junior testers, fostering a culture of continuous improvement. Analyze test results to provide actionable insights for product enhancements. Engage with stakeholders to communicate testing outcomes and recommendations. Drive innovation in testing methodologies to improve efficiency and effectiveness. Show excellent communication skills for effective stakeholder engagement. Display a proactive approach to problem-solving and process improvement. Maintain a commitment to continuous learning and professional development. 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 09/05/2025. The annual salary for this position is between $71,100 - $112,500 depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans. Benefits
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements: 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.
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Cognizant Technology Solutions is looking for “ Validation Lead (GxP & Life Sciences Domain) ” to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you! About Cognizant’s QEA Practice We are the largest Quality Assurance Practice Globally servicing 800+ Clients. We bring the industry leading vision and expertise to help with Quality Engineering transformation journey for our reputed clients. We provide Next Gen QA offerings like 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 times in a row and ranked #1 for completeness of vision, test advisory and Digital Business Assurance in Gartner Magic Quadrant! Role Location : Boston, MA (Remote) Required Qualifications
Deep Knowledge of GxP Regulations Strong understanding of FDA, EMA, MHRA, and other global regulatory requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5). Validation Lifecycle Expertise Proficiency in managing the full validation lifecycle: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports. Strong Documentation and Audit Readiness Skills Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. Proven track record in preparing for internal and external audits Life Sciences Domain Expertise Familiarity with pharmaceutical industry Strong experience in manufacturing domain and systems like OPM, Informatica, Veeva QMS & DMS, ARVETO 3PL, Oracle Transportation, Global Trade Management, Oracle EBS Leadership and Stakeholder Management Ability to lead cross-functional teams and coordinate with QA, IT, and business stakeholders. Skilled in managing validation deliverables across geographies and time zones Risk-Based Validation and Process Optimization Experience in risk assessment, deviation handling, CAPA management, and process harmonization. Familiarity with Agile, Waterfall, and V-Model SDLC approaches Technical Proficiency and Tool Familiarity Proficient in tools like HP ALM, JIRA, ServiceNow, SharePoint Comfortable with data validation, integration testing, and analytics platforms Responsibilities
Lead the testing strategy for Document Management Systems, ensuring robust and efficient processes. Oversee interoperability validation to guarantee seamless integration across platforms. Coordinate CSV activities to ensure compliance with regulatory standards. Utilize ALM tools to manage and streamline testing workflows. Collaborate with research and development teams to align testing with project goals. Develop comprehensive test plans and cases to cover all functional and non-functional requirements. Monitor and report on testing progress, identifying, and addressing any issues promptly. Ensure all testing activities adhere to company policies and industry best practices. Mentor and guide junior testers, fostering a culture of continuous improvement. Analyze test results to provide actionable insights for product enhancements. Engage with stakeholders to communicate testing outcomes and recommendations. Drive innovation in testing methodologies to improve efficiency and effectiveness. Show excellent communication skills for effective stakeholder engagement. Display a proactive approach to problem-solving and process improvement. Maintain a commitment to continuous learning and professional development. 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 09/05/2025. The annual salary for this position is between $71,100 - $112,500 depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans. Benefits
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements: 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.
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