Computer System Validation Lead, Program Manager

Veeva Systems

Confirmed live yesterday Trusted
Remote

Quick summary

Work type
Remote
Location
Columbus, OH
Salary
$85,000–$120,000 / yr
Posted
137 days ago
Freshness
Confirmed live yesterday

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $184k
This role $102k
$68k most similar roles pay here $243k

This role pays less than 98% of similar roles. Most pay $153,687–$214,000 — the shaded band above. At the midpoint, this role pays about $102k versus about $184k for comparable roles.

Based on 240 similar postings.

Employer

About Veeva Systems

Veeva Systems is a cloud software company serving the global life sciences industry, providing CRM, clinical, regulatory, quality, and data applications used by pharmaceutical and biotech companies.

Veeva Systems currently has 93 open roles on FindRole.

Listed pay typically runs $80,000–$165,000 across 82 roles with salary data.

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View all roles at Veeva Systems

At a glance

TL;DR · Computer System Validation Lead, Program Manager

As a Computer System Validation Lead / Program Manager, you will join the team responsible for providing cloud-based digital validation for life sciences products including eTMF, CTMS, QMS, and LIMS. You will lead and execute validation activities for general releases, hot fixes, and periodic revalidations while ensuring compliance with industry regulations such as 21CFR211, Part 820, Part 11, Annex 11, and ICH Q10. Your daily responsibilities include developing deliverables like Business Requirements, Risk Assessments, Validation Plans, IQ/OQ scripts, and Trace Matrices while collaborating with cross-functional teams to maintain a validated state. You will provide technical expertise in regulatory interpretation and risk-based testing. Required skills include experience with enterprise applications, Agile methodologies, and knowledge of standards like ISO 9001 and GAMP 5 to solve complex compliance challenges within the life sciences domain.

What you'll do

  • Lead and execute validation activities for general releases, hot fixes, and periodic revalidations of Veeva products.
  • Manage the validation process to ensure all deliverables meet pre-scheduled release dates and budgets.
  • Provide technical expertise and regulatory interpretation regarding 21CFR Part 11, Annex 11, and other industry standards.
  • Create and update CSV deliverables including IQ/OQ, Validation Plans, Summary Reports, and Traceability Matrices.
  • Perform risk assessments and validation impact analyses in coordination with product teams.
  • Identify, log, and prioritize issues found during validation execution to ensure timely resolution.
  • Ensure all requirements are tested using a risk-based approach and maintain clear traceability.
  • Support change control processes as the primary technical resource for validation tasks.

What we're looking for

  • Bachelor’s degree in Engineering, Sciences, or equivalent relevant technical experience.
  • At least 3+ years of experience in a CSV role.
  • Hands-on experience with the validation of enterprise applications used in commercial regulated activities and industry applications.
  • Good understanding of relevant industry regulations including 21CFR11, Annex 11, 21CFR211, 21CFR312, 21CFR203, and 21CFR820.
  • Knowledge of industry standards such as ISO 9001, ASTM E2500, and ISPE Baseline Guides.
  • Familiarity with Agile software development, business analysis, and/or software testing methodologies.
  • Excellent written and oral communication, decision-making, and time management skills.
  • Experience with cloud-based applications, mobile applications, infrastructure compliance, CSA, RBV, AI validation, or GAMP 5 (preferred).

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