Computer System Validation Lead / Program Manager

Veeva; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible PTO

Retirement programs

1% charitable giving program

Job summary

Veeva seeks a Computer Systems Validation Lead / Program Manager to drive validation for eTMF, CTMS, QMS, LIMS, and related cloud-based software across releases and patches.

You will plan, execute, and govern CSV deliverables (IQ/OQ, VPP, VSR, risk assessments) ensuring regulatory compliance and end-to-end traceability. Collaborate with Product, SQA, and IT teams to deliver high-quality validation artifacts.

Qualifications

• Bachelor’s degree in Engineering, Sciences or equivalent relevant technical experience.
• 3+ years of experience in a CSV role.
• Hands-on validation of enterprise applications in regulated environments.
• Familiarity with 21 CFR 11 and ISO standards.

Responsibilities

• Lead validation activities for general releases, hot fixes, and revalidations.
• Develop and execute CSV deliverables (IQ/OQ, VPP, VSR, trace matrices).
• Ensure regulatory compliance and traceability across the validation lifecycle.
• Collaborate with Product, SQA, and IT to maintain validated state of systems.

Skills

CSV

Regulatory knowledge

Risk assessment

Test planning

Agile methods

Communication

Traceability

Education

Bachelor’s degree in Engineering/Sciences

Tools

SAP

eTMF

CTMS

LIMS

QMS

DCS

Job description

The Role

Join Veeva as we bring the power of modern, cloud-based digital validation to the industry. As a Computer Systems Validation Lead / Program Manager, you’ll lead the Validation supporting Veeva products (eTMF, CTMS, QMS, LIMS, etc.) – helping life sciences companies speed their adoption of a unified, cloud-based platform leveraging Veeva Validation documentation.

We are seeking an experienced CSV professional to plan and support ongoing validation activities that includes general releases and patches/hot fixes for Veeva’s Quality applications. Drives the computer validation/qualification activities including developing/executing CSV deliverables (Business/Functional Requirements, Risk Assessments, Validation Plans/ Protocols, IQ, OQ, Validation Summary). Provides technical validation expertise, interpretation, and direction to assure compliance with industry and regulatory requirements (e.g., 21CFR211, Part 820, Part 11, Annex 11, ICH Q10, etc.), company policies and standards regarding validation, document control and change management.

In this role, you’ll act as a trusted CSV planner, advisor, and partner with other Veeva teams. Through this partnership, you and your Veeva teams will deliver consistent and high‑quality deliverables supporting Veeva life‑sciences customers.

Responsibilities

• Lead and execute the validation activities for Veeva’s general releases, hot fixes, and product periodic revalidation.
• Track, monitor, and control the validation process to ensure timely delivery to meet pre‑scheduled release dates and budgets.
• Provide technical expertise, regulatory interpretation, and direction regarding computer validation, federal regulations, and other quality system requirements.
• Collaborate closely with the Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format.
• Work with cross‑functional teams (Product Management, SQA, Technical Operations, IT Engineering, etc.) to maintain the validated state of the system.
• Ensure requirements are adequately tested following a risk‑based approach.
• Identify and log issues found during validation execution; work closely with Product and SQA teams to prioritize issues early and track validation incidents to closure.
• Ensure clear traceability against all testing performed.
• Create and update CSV deliverables (IQ/OQ, VPP, VSR, Trace Matrices).
• Conduct independent pre‑ and post‑execution review of validation test scripts.
• Coordinate with cross‑functional teams to design and execute test protocols.
• Support change control as a validation technical resource and ensure timely completion of required tasks.
• Perform validation impact analysis and risk assessments in collaboration with product teams.
• Execute other projects or duties as assigned to ensure compliance across Veeva’s product line and internal business systems.

Qualifications

• 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 (e.g., SAP) used in commercial regulated activities (Good Distribution Practice) and/or supporting industry applications (e.g., eTFM, CTMS, LIMS, Quality Management, DCS, etc.).
• Good understanding of industry regulations (e.g., 21CFR11, 21CFR211, 21CFR312, 21CFR203, 21CFR820, etc.) and industry standards/principles (ISO 9001, ASTM E2500, ISPE Baseline Guides).
• Familiarity with Agile software development, business analysis, and/or software testing methodologies.
• Excellent written and oral communication skills, good decision‑making skills, and time‑management skills.
• Experience with cloud‑based applications, mobile applications, and/or infrastructure compliance.
• Understanding of Agile development methodology.
• Understanding of CSA, RBV, use and validation of AI in the life sciences.
• Working knowledge of GAMP 5.

Benefits

• Medical, dental, vision, and basic life insurance.
• Flexible PTO and company paid holidays.
• Retirement programs.
• 1% charitable giving program.

Compensation

Base pay: $85,000 – $120,000. The salary range listed here is provided to comply with local regulations and represents a potential base salary range for this role. Actual salaries may vary within the range above or below, depending on experience and location. This position may also be eligible for other types of compensation such as variable bonus and/or stock bonus.

Veeva is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact [e-mail].