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

Perks & Benefits

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

Compensation

• Base pay: $65,000 - $120,000  
• 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.