Senior Technical Lead
United States
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Job Description
Senior Technical Lead
Somerset, New Jersey

Job Summary

  • 8 to 10 yrs in medical devices, biotechnology with direct CSV exp
  • Practical knowledge of GxP regulations and standards – 21 CFR part 11, Part 210/211, GAMP 5, EU Annex 11, security and privacy requirements
  • Exp in leading GxP infrastructure qualification and quality oversight of on prem or cloud environments with working knowledge of networks, databases, virtualization, ITIL process, disaster recovery and infrastructure security controls
  • Exp with Jira/Xray, qtest or equivalent ALM/test platforms
  • Looking for an offshore resource to support a fast-paced ongoing validation project. Some of the high-level requirements for this role are -
  • A senior consultant with expert knowledge of GxP and Computer System Validation.
  • Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
  • Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc.
  • Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
  • Prefer an individual with great communication skills, ability to work proactively and independently.
  • Ability to interact and lead conversations and meeting with Business

Partners independently to lead and guide GxP policies and regulations. Interact with technology partners to ensure compliant working and operation of supported GxP systems.

Key Responsibilities

  • 8 to 10 yrs in medical devices, biotechnology with direct CSV exp
  • Practical knowledge of GxP regulations and standards – 21 CFR part 11, Part 210/211, GAMP 5, EU Annex 11, security and privacy requirements
  • Exp in leading GxP infrastructure qualification and quality oversight of on prem or cloud environments with working knowledge of networks, databases, virtualization, ITIL process, disaster recovery and infrastructure security controls
  • Exp with Jira/Xray, qtest or equivalent ALM/test platforms
  • Looking for an offshore resource to support a fast-paced ongoing validation project. Some of the high-level requirements for this role are -
  • A senior consultant with expert knowledge of GxP and Computer System Validation.
  • Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
  • Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc.
  • Proficient knowledge of CFR Part 11 regulations and Quality Management Regulations.
  • Prefer an individual with great communication skills, ability to work proactively and independently.
  • Ability to interact and lead conversations and meeting with Business

Partners independently to lead and guide GxP policies and regulations. Interact with technology partners to ensure compliant working and operation of supported GxP systems.

Skill Requirements

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Other Requirements
Maximum Salary (US): 
Minimum Salary (US): 
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Information at a Glance

Why HCLTech?

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 2026 totaled $14.8 billion. 

 

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); and 10 paid holidays per year.