Cognizant
Overview
GxP Validation Lead : QA Life Sciences (Onsite) – Cognizant Technology Solutions. We are seeking a QA Life Sciences GxP Validation Lead to join our team in a permanent, onsite role in Boston, MA. About Cognizant’s QEA Practice: We are the largest Quality Assurance practice globally, serving 800+ clients. We offer Next Gen QA capabilities including System Modernization Assurance, Business Process Assurance, Quality Engineering, Cloud Platform Assurance, Customer Experience Assurance and Robotic Test Automation. We have been recognized for market impact and completeness of vision by Everest Group and Gartner Magic Quadrant. Qualifications
QA Lead with about 9 to 12 years of experience: 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 the Pharmaceutical Industry Strong experience in Clinical and Regulatory domains and systems like Veeva Vault QMS, DMS (preferred) 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 Roles & 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 Demonstrate 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 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 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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GxP Validation Lead : QA Life Sciences (Onsite) – Cognizant Technology Solutions. We are seeking a QA Life Sciences GxP Validation Lead to join our team in a permanent, onsite role in Boston, MA. About Cognizant’s QEA Practice: We are the largest Quality Assurance practice globally, serving 800+ clients. We offer Next Gen QA capabilities including System Modernization Assurance, Business Process Assurance, Quality Engineering, Cloud Platform Assurance, Customer Experience Assurance and Robotic Test Automation. We have been recognized for market impact and completeness of vision by Everest Group and Gartner Magic Quadrant. Qualifications
QA Lead with about 9 to 12 years of experience: 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 the Pharmaceutical Industry Strong experience in Clinical and Regulatory domains and systems like Veeva Vault QMS, DMS (preferred) 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 Roles & 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 Demonstrate 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 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 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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