Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM)

Job Title: Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM)

Position Summary

We are seeking experienced Validation/Test professionals-including a Validation/Test Lead and multiple Testers-to support a large-scale Veeva Quality implementation within a regulated (GxP) environment.

The ideal candidates will have hands-on experience with Computer System Validation (CSV) processes, creation and execution of regulated validation deliverables, and a strong understanding of Supplier Quality Management (SQM) and Quality Risk Management (QRM) business processes. Familiarity with Veeva Vault Quality Suite (QMS, QualityDocs, Training) and associated validation methodologies is essential.

Key Responsibilities

Validation/Test Lead

• Lead planning, coordination, and execution of end-to-end validation and testing activities across multiple Veeva modules (e.g., QMS, QualityDocs, Training, Vault Platform).
• Develop and manage Validation Master Plan (VMP), Test Strategy, and Traceability Matrices in compliance with GxP and CSV requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Oversee preparation and review of validation documentation, including Requirements, Functional Specifications, Risk Assessments, IQ/OQ/PQ, and Test Scripts.
• Coordinate with business process SMEs (SQM, QRM), IT, and implementation partners to ensure test coverage aligns with both business and regulatory requirements.
• Manage defect triage, test execution tracking, and validation summary reporting.
• Support audits and inspections by providing validation evidence and documentation.
• Mentor and guide testers to ensure consistent validation quality and adherence to procedures.

Testers

• Author, review, and execute test scripts in accordance with approved validation protocols and standards.
• Accurately record test results, defects, and objective evidence in compliance with documentation requirements.
• Validate workflows and configurations related to SQM (Supplier Qualification, Audits, Performance) and QRM (Risk Identification, Assessment, Mitigation).
• Collaborate with business and IT teams to ensure clear understanding of requirements and test expectations.
• Contribute to preparation of Validation Summary Reports (VSRs) and ensure traceability from requirements to test results.
• Support regression testing and revalidation activities post-deployment or system enhancement.

Qualifications

Required:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field.
• 5+ years (Lead) or 2+ years (Tester) of experience in Computer System Validation (CSV) or regulated system testing in the pharmaceutical/biotech industry.
• Proven experience with GxP systems validation following GAMP 5 and 21 CFR Part 11 guidelines.
• Hands-on experience with Veeva Vault Quality applications (e.g., QMS, QualityDocs, Training).
• Familiarity with SQM and QRM business processes and related documentation/workflows.
• Strong understanding of validation lifecycle deliverables and traceability.
• Excellent written and verbal communication skills, with attention to documentation detail.

Preferred:

• Prior experience on a Veeva implementation or rollout within a regulated organization.
• Experience working with Merck or similar large pharma quality systems and validation frameworks.
• Knowledge of Agile or hybrid project methodologies for validation.
• Proficiency with test management tools (e.g., HP ALM, Jira, Zephyr, TestRail).