Validation Lead - Commercial Products
Columbus, OH, USA
Posted on Tuesday, December 15, 2020
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 Validation Lead for Commercial Products provides Computer Systems Validation support to the Quality and Compliance function in support of Veeva commercial product validation. Primarily responsible for supporting the ongoing validation activities across the commercial products (e.g., CRM, Engage, PromoMats), including general releases and patches/hotfixes. 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, 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, hotfixes, 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 in regard to computer validation, federal regulations, and other quality system requirements.
- Closely collaborate with 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.
- Bachelor’s degree in Engineering/Sciences or equivalent relevant technical experience
- At least 5+ years of experience in CSV role.
- Hands-on experience with the validation of commercial enterprise applications (e.g., SFDC, SAP) used in the conduct of commercial regulated activities (Good Distribution Practice).
- Good understanding of the commercial industry regulations (e.g., PDMA, OIG, Sunshine Act, 21CFR203).
- 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
- Experience with cloud-based applications and/or infrastructure compliance
- Understanding of Agile development methodology
- Working knowledge of GAMP 5
- Broader awareness or direct experience with “promotional materials” requirements (e.g., OPDP, APLB)
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@example.com. Position may not be eligible for remote work in Colorado.
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