Computer System Validation Lead / Program Manager

About the role

Join Veeva as we bring the power of modern, cloud-based digital validation to the industry. As a Computer Systems Validation Lead/Program Manager, you’ll lead the Validation supporting Veeva products (e.g., eTMF, CTMS, QMS, LIMS, etc.).

Responsibilities

• 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 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 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, IT Engineering, etc.) 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.
• Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices.
• Independent pre and post execution review of validation test scripts.
• Coordinate 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., SAP) used in the conduct of commercial regulated activities (Good Distribution Practice) and / or supporting industry applications (e.g., eTMF, CTMS, LIMS, Quality Management, DCS, etc.).
• Good understanding of the relevant industry regulations (e.g., 21CFR11 / Annex 11, 21CRF211, 21CFR312, 21CFR203, 21CFR820, etc.) as well as industry standards/principles (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 skills and time management skills.
• Experience with cloud-based applications, mobile applications and/or infrastructure compliance
• Understanding of Agile development methodology
• Understanding of CSA, RBV, use and Validation of AI in the life-sciences
• Working knowledge of GAMP 5

Qualifications

• Experience with cloud-based applications, mobile applications and/or infrastructure compliance
• Understanding of Agile development methodology
• Understanding of CSA, RBV, use and Validation of AI in the life-sciences
• Working knowledge of GAMP 5

Skills

• Technical expertise in computer systems validation
• Strong regulatory and compliance knowledge
• Ability to interpret and apply industry standards and regulations
• Excellent communication and interpersonal skills
• Experience with Agile methodologies and project management
• Knowledge of cloud-based technologies and infrastructure compliance
• Experience with AI and its validation in the life-sciences
• Experience with GAMP 5 principles

Benefits

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

Pay

Base pay: $85,000 - $120,000

Schedule

This is a work anywhere, full-time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you.