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Veeva Qms Qa Lead

Vlink Inc.
VLink Inc.
8+ years
$65 - $75 Per Hour
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: BCS/BE/B.Sc. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Veeva QMS QA Lead

Location: Boston, MA
Duration: Long-Term Contract


Role Overview

The Veeva QMS QA Lead will play a key role in overseeing and ensuring the validation and quality assurance of Quality Management Systems (QMS) in the pharmaceutical domain. This position requires hands-on expertise with tools like Veeva or TrackWise, a deep understanding of regulatory requirements such as GxP and 21 CFR Part 11, and strong leadership skills to manage cross-functional and geographically diverse teams.


Key Responsibilities

  • Lead the implementation, validation, and maintenance of QMS tools, specifically Veeva or TrackWise.
  • Develop and oversee validation documentation including IQ, OQ, PQ, and test management strategies using HP ALM for traceability.
  • Ensure compliance with relevant pharmaceutical regulations, including GxP, 21 CFR Part 11, and other standards.
  • Manage and coordinate onshore and offshore QA and validation teams, ensuring seamless collaboration.
  • Develop risk mitigation strategies and resolve quality assurance issues effectively.
  • Prepare and manage external audits, ensuring readiness for regulatory compliance.
  • Collaborate with cross-functional teams to align on project goals and objectives.
  • Provide guidance on validation best practices and ensure thorough documentation throughout the lifecycle of projects.

Qualifications

Educational Background:

  • Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field.

Experience & Skills:

  • 8+ years of quality assurance and validation experience in the pharmaceutical industry.
  • Expertise in managing and validating Quality Management Systems (QMS) such as Veeva or TrackWise.
  • Proficiency in validation processes, including IQ, OQ, PQ, and test management with HP ALM.
  • Thorough understanding of GxP, 21 CFR Part 11, and pharmaceutical industry regulations.
  • Proven ability to manage validation and QA teams across different locations.
  • Strong project management skills, with a demonstrated ability to handle multiple projects simultaneously.
  • Experience managing external audits and ensuring regulatory compliance readiness.
  • Excellent problem-solving, communication, and documentation skills.

About VLink Inc.

VLink Inc. is a trusted IT and staffing solutions partner for organizations worldwide. We specialize in delivering tailored services to meet the unique needs of our clients, ensuring high-quality outcomes through innovative solutions and expert teams.


To Apply:

VLink Inc. is an equal-opportunity employer and values diversity in the workplace.