GxP Validation Lead : QA Life Sciences (Onsite)

Overview

GxP Validation Lead : QA Life Sciences (Onsite) – Cognizant Technology Solutions is seeking a GxP Validation Lead : QA Life Sciences(Onsite) to join our team 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!

Onsite Location : Boston, MA

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 !!

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

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 :

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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