Computer System Validation Lead / Program Manager

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

Benefits offered by this job

Medical, dental, vision, and life insurance

Flexible PTO and company-paid holidays

Retirement program

1% charitable giving program

Job summary

Veeva Systems seeks a Computer Systems Validation Lead / Program Manager in Boston, MA. The role involves leading validation activities for Veeva's quality applications, ensuring regulatory compliance. Candidates should possess a Bachelor's degree in Engineering or related fields and 3+ years of CSV experience. Key responsibilities include executing validation, collaborating with teams, and maintaining compliance across product lines. Benefits include medical insurance, flexible PTO, and a retirement program.

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 validating enterprise applications used in regulated activities.

Responsibilities

• Lead and execute validation activities for Veeva’s quality applications.
• Collaborate with Product Teams to define compliant requirements.
• Conduct independent pre-and post-execution review of validation test scripts.

Skills

Validation of enterprise applications

Understanding of relevant industry regulations

Excellent written and oral communication skills

Agile software development

Decision-making and time-management

Education

Bachelor’s degree in Engineering or Sciences

Tools

SAP

GAMP 5

Job description

Veeva Systems is a mission-driven organization that helps life sciences companies bring therapies to patients faster. We are a public benefit corporation committed to balancing the interests of customers, employees, society, and investors.

Overview

The Computer Systems Validation Lead / Program Manager will lead and support validation activities for Veeva’s quality applications, ensuring compliance with industry and regulatory requirements.

Responsibilities

• Lead and execute validation activities for general releases, hot fixes, and periodic revalidations.
• Track, monitor, and control the validation process to meet release schedules and budgets.
• Provide technical expertise and regulatory interpretation for computer validation and quality system requirements.
• Collaborate with Product Teams to define clear, testable, and compliant requirements.
• Work with cross‑functional teams (Product Management, SQA, Technical Operations, IT Engineering, etc.) to maintain the validated state of the system.
• Ensure requirements are tested according to a risk‑based approach.
• Identify and log validation issues; prioritize and track incidents to closure.
• Maintain traceability for 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; ensure timely completion of required tasks.
• Perform validation impact analysis and risk assessments with product teams.
• Execute additional projects and duties as assigned to ensure compliance across Veeva’s product line.

Requirements

• Bachelor’s degree in Engineering, Sciences, or equivalent relevant technical experience.
• At least 3+ years of experience in a CSV role.
• Hands‑on experience validating enterprise applications (e.g., SAP) used in regulated activities or industry applications.
• Strong understanding of relevant industry regulations (e.g., 21CFR11 / Annex 11, 21CRF211, 21CFR312, 21CFR203, 21CFR820) and standards (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 and time‑management abilities.

Nice to Have

• Experience with cloud‑based applications, mobile applications, or infrastructure compliance.
• Understanding of Agile development methodology.
• Knowledge of CSA, RBV, AI validation in life sciences.
• Working knowledge of GAMP 5.

Benefits

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

Compensation

• Base pay: $85,000 – $120,000.
• Compensation may include variable or stock bonuses and may vary based on experience and location.

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 us at [e-mail].