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Senior Technical Lead

Job in Edison, Middlesex County, New Jersey, 08818, USA
Listing for: HCL Technologies Limited
Full Time position
Listed on 2026-09-26
Job specializations:
  • Quality Assurance - QA/QC
    IT QA Tester / Automation, QA Specialist - Analyst/Manager, Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 170000 USD Yearly USD 110000.00 170000.00 YEAR
Job Description & How to Apply Below
  • Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem
  • Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
  • Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
    Define and implement Risk based validation activities.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs). Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations to TQ management

Key Responsibilities
  • Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem
  • Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
  • Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
    Define and implement Risk based validation activities.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs). Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
  • Strong verbal and written communication skills.
  • Ability to work as a team player, lead a team or accomplish tasks without supervision.
  • Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations to TQ management

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services.

Consolidated revenues as of 12 months ending June 2026totaled $14.8billion.

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies.

In addition, this role is eligible for the following benefits subject to company policies:

  • medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance
  • employee assistance program
  • 401(k) retirement plan
  • 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year)
  • 10 paid holidays per year
Position Requirements
10+ Years work experience
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