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Cognizant Technology Solutions is looking for “ Regulatory Compliance Manager (GXP) ” to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for 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 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!

Regulatory Compliance Manager (GXP)

Location: Cambridge, MA (Hybrid)

Required Qualifications

• Bachelor’s Degree in Computer Science, Sciences or a related education (e.g. life science, medicine, commercial), Masters preferable
• Excellent understanding of Pharma GXP assessment, FDA predicate rules
• Through knowledge on what is a GxP system vis a vis Non GxP system
• Explain meaning of GXP assessment, each line to business in case of conflict of understanding
• Excellent communication skills to talk to Client business users
• Question on why systems were Non GXP.
• Give some leading questions and probe

Roles/Responsibilities

• Assessment of SOPs
• Identify key risks
• Skills to liaise with Client Business Senior stakeholders
• Process assessment adherence / Compliance assessment experience
• Mitigate risks keeping industry best practices as part of mitigation plan
• Conduct interviews with Business to clarify and recommend solutions
• Publish draft guidelines and take it for approval
• Continuous improvement by enabling periodic review of Process adherence
• Prepare report after each session with finding and present final assessment report with recommendations to IT for areas of change

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

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.