Validation Lead/Program Manager @ Veeva Systems

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We’re not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

The Computer Systems Validation Lead / Program Manager – Vault Platform role provides Computer Systems Validation support to the Quality and Compliance function in support of the Vault Platform.

Primarily responsible for supporting the ongoing validation activities for the Vault Platform including general releases and patches/hot fixes encompassing key functionally used by Vault Applications (e.g., Audit Trail, Electronic Signature, Security, Workflows, Objects, Lifecycles, etc.). 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., PDMA, OIG, 21CRF Part 11, Eudralex Annex 11, etc.), company policies and standards regarding validation, document control, and change management.

What You’ll Do

Lead and execute (as needed) the validation activities for Veeva’s general releases, hot-fixes, as well as product periodic revalidation
Responsible for tracking, monitoring, and controlling 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
Closely collaborate with the Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format
Effectively work with cross-functional teams (Product Management, SQA, Technical Operations) to ensure the validated state of the system is maintained
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 identify and prioritize issues early on and track validation incidents to closure
Ensure clear traceability against all testing performed
Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices
Independent pre and post-execution review of validation test scripts
Coordinates with cross-functional teams to design and execute test protocols
Supports change control as validation technical resource and ensures timely completion of required tasks
Perform validation impact analysis and risk assessments in conjunction with product teams
Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems

Requirements

Bachelor’s degree in Engineering/ Sciences or equivalent relevant technical experience
At least 3+ years of experience in CSV role
Hands-on experience with the validation of enterprise applications (e.g., SFDC, SAP) used in the conduct of commercial regulated activities (Good Distribution Practice) and/or supporting industry applications (e.g., eTFM, CTMS, Quality Management, etc.)
Good understanding of the relevant industry regulations (e.g., 21CFR11, 21CRF211, 21CFR312, etc.)
Knowledge of Agile software development, and software testing methodologies
Excellent written and oral communication skills, good decision-making skills, and time management skills

Nice to Have

Hands-on experience with the validation of Vault applications
Experience with cloud-based applications and/or infrastructure compliance
Understanding of Agile development methodology
Working knowledge of GAMP 5

Perks & Benefits

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

Compensation

Base pay: $60,000 - $150,000
The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

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Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

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 [email protected].

What You’ll Do

Requirements

Nice to Have

Perks & Benefits

Compensation

6 month growth

1 year growth

2 year growth

Benefits