Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 875 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Canada, Europe, Asia, and Latin America. Veeva is growing to 10,000 employees by 2025, so visit the Jobs section for open positions and remember that correspondence to new applicants and existing candidates will only come from an official @veeva.com email address.

As a Business Analyst, you will work closely with the product management and quality compliance teams translating design documents into functional specifications. System process mapping and business requirements are to be well documented in order to deliver high-quality solutions.

What You'll Do

• Transform and maintain current and future design documents into functional business requirements in cooperation with Product Management
• Ensure the quality and timeliness of the requirements process to drive prompt and efficient validation processes
• Confirm consistent traceability of design documents to functional business requirements
• Evaluate and prioritize requirements for risk-based validation testing based on impacting government regulations
• Work with compliance and validation teams to communicate requirements in a manner that allows for efficient and effective validation outputs

Requirements

• 5+ years of direct experience with business analysis experience and demonstrable experience with computer systems validation preferably within the pharmaceutical industry
• Strong background in business process analysis, requirements engineering, and process design modeling
• Excellent verbal and written communication with the ability to present complex design concepts with clear and concise requirements
• Experience reviewing test scenarios & test scripts
• Self-motivated, resourceful, and able to meet responsibilities with minimal direct supervision
• Experience with 21 CFR Parts 11 and 203
• Experience with Prescription Drug Marketing Act (PDMA)
• Bachelor’s Degree from a 4 year accredited institution

Nice to Have

• Experience with SaaS based solutions, especially Salesforce.com or Veeva Vault