Cognizant Technology Solutions
GxP Validation Lead : QA Life Sciences (Onsite)
Cognizant Technology Solutions, Boston, Massachusetts, us, 02298
GxP Validation Lead: QA Life Sciences (Onsite)
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. Cognizant Technology Solutions is seeking a \"GxP Validation Lead: QA Life Sciences(Onsite)\" to join our team of IT professionals in a permanent role. If you meet our background requirements and skills and are seeking 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 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 ranked #1 for completeness of vision, test advisory and Digital Business Assurance in Gartner Magic Quadrant.
Onsite Location: Boston, MA
Qualifications QA Lead with about 9 to 12 yrs. 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 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.
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 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.
The Cognizant community:
Cognizant is a global community with more than 300,000 associates around the world.
We don't just dream of a better way - we make it happen.
We take care of our people, clients, company, communities and climate by doing what's right.
We foster an innovative environment where you can build the career path that's right for you.
About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World\'s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. Cognizant Technology Solutions is seeking a \"GxP Validation Lead: QA Life Sciences(Onsite)\" to join our team of IT professionals in a permanent role. If you meet our background requirements and skills and are seeking 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 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 ranked #1 for completeness of vision, test advisory and Digital Business Assurance in Gartner Magic Quadrant.
Onsite Location: Boston, MA
Qualifications QA Lead with about 9 to 12 yrs. 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 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.
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 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.
The Cognizant community:
Cognizant is a global community with more than 300,000 associates around the world.
We don't just dream of a better way - we make it happen.
We take care of our people, clients, company, communities and climate by doing what's right.
We foster an innovative environment where you can build the career path that's right for you.
About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World\'s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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