Massachusetts Education Jobs

Cognizant Technology Solutions is currently seeking a highly skilled Test Program Manager with GxP and Validation Exp. who will be responsible for Overall delivery and participate in Project discussions /Project Roadmap / Strategy.

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!

Test Program Manager with GxP and Validation Exp.

Onsite Location: Boston – MA (preferred)

Required Skills

15+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and 5+ years in a management role.

Regulatory Knowledge: Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements; experience with GAMP and validation processes.

Demonstrated success in working with diverse teams, including QA, regulatory, and business customers, to achieve shared goals.

CSV/CSA Expertise: In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.

Strong with writing Test Strategies

Strong Test Program management skills

Hands on & closer to delivery with Cross-Functional Collaboration:

Knowledge on ALM Test management tool

Project Management: Solid project management skills, with the ability to manage complex test programs, resource allocation, and timelines.

Communication & Reporting: Excellent written and verbal communication skills, including the ability to prepare clear reports and conduct stakeholder meetings effectively

Data testing; Salesforce, Veeva testing (good to have)

Automation: Exposure to test automation frameworks (good to have)

Education: Bachelor’s degree in computer science, Life Sciences, or a related field; advanced degree preferred.

Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications.

Roles and Responsibilities

Develop and implement comprehensive Validation and Test strategies aligned with regulatory requirements such as FDA, EMA, and GxP standards, supporting the transition to CSA.

Identify new areas for penetration, partner with key customers to showcase the testing and validation capabilities of various solutions across pharm domain, and develop plans to move these initiatives forward

Define objectives and priorities for Validation and testing activities across clinical, regulatory, and manufacturing systems, focusing on digital transformation and paperless execution.

Collaborate with project partners, including regulatory and compliance teams, to establish Validation and testing protocols and ensure adherence to CSV/CSA principles.

Define strategy and support transitioning from paper-based to ALM / Test management tool in compliance with regulatory requirements.

Handle end-to-end Validation and test phases for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation.

Ensure compliance with industry regulations, including 21 CFR Part 11, focusing on Good Automated Manufacturing Practices (GAMP).

Lead risk-based Validation and testing efforts to mitigate compliance risks across applications

Define standard to Design and complete Validation and test scripts that confirm systems meet GxP and CSV/CSA standards, ensuring they are audit ready.

Define standards to maintain detailed documentation of test results, issues, and resolutions to support regulatory audits and digital transition inspections.

Find opportunities for Test automation and work with Architects and Automation specialist to implement

Ensure adoption of automated testing tools and frameworks suitable for pharmaceutical applications, ensuring they meet validation and CSA requirements.

Continuously review and refine testing processes, contributing to improved productivity, quality, and compliance with digital initiatives.

Act as the primary liaison between QA, regulatory, and business teams, providing regular updates on testing progress & outcomes

Prepare comprehensive reports on Validation and testing activities, including transformation progress.

Lead regular meetings with partners to discuss Validation and testing plans, CSA outcomes, and opportunities for continuous improvement !

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.)

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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