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GxP Validation Lead
- Cognizant (Boston, MA)
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About the role
As a **Validation & Testing Lead in Life Sciences** , you will make an impact by driving the validation and testing strategy for Document Management Systems (DMS) and ensuring compliance with global regulatory standards. You will be a valued member of the Life Sciences team and work collaboratively with cross-functional stakeholders including QA, IT, and business units across geographies.
In this role, you will:
+ Lead the testing strategy for Document Management Systems, ensuring robust and efficient validation processes.
+ Oversee interoperability validation to guarantee seamless integration across platforms.
+ Coordinate Computer System Validation (CSV) activities to ensure alignment with FDA, EMA, MHRA, and other global regulatory requirements.
+ Utilize ALM tools to manage and streamline testing workflows and documentation.
+ Collaborate with research and development teams to align testing efforts with project goals and timelines.
Work model:
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a **hybrid position requiring 2–3 days a week** in a client or Cognizant office in **Boston, Massachusetts** . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.
What you need to have to be considered:
+ Deep knowledge of GxP regulations and global compliance standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
+ Proven expertise in the full validation lifecycle: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports.
+ Strong documentation and audit readiness skills, including authoring SOPs and validation plans.
+ Experience in Clinical and Regulatory domains, with familiarity in systems like Veeva Vault QMS and DMS.
+ Proficiency in tools such as HP ALM, JIRA, ServiceNow, and SharePoint.
These will help you stand out:
+ Demonstrated leadership in mentoring junior testers and fostering a culture of continuous improvement.
+ Experience in risk-based validation, deviation handling, CAPA management, and process harmonization.
+ Ability to lead cross-functional teams and manage validation deliverables across time zones.
+ Familiarity with Agile, Waterfall, and V-Model SDLC approaches.
+ Strong stakeholder engagement and communication skills, with a proactive approach to problem-solving.
+ Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
•** **_Salary and Other Compensation:_
• The annual salary for this position is between [$71,100/- to $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
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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