Director of Validation & Compliance for GxP Systems

Veeva Systems; Boston (MA); Remote; USD 150.000 - 230.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision, basic life

Flexible PTO & holidays

Retirement programs

1% charitable giving

Zusammenfassung

Veeva Systems is a mission-driven SaaS leader in life sciences. The Director of Computer Systems Validation Program will oversee validation teams, ensuring on-time, on-budget delivery across software validation, audits, and AI-driven capabilities.

The role emphasizes risk-based approaches, regulatory compliance, and leadership of multi-site teams. The position offers flexible work options as a Work Anywhere company, with responsibilities spanning planning, validation strategy, and

Qualifikationen

• Bachelor's degree in engineering/sciences or related field.
• 10+ years in validation of enterprise software in life sciences regulated env.
• Experience with risk-based validation and AI/ML governance in life sciences.
• Previous managerial experience (5+) demonstrated leadership and budgeting.
• Familiarity with 21 CFR Part 11 and related GxP regulations.
• Experience with GCPs, GMPs, and software validation activities.
• Strong project management and technical writing skills.

Aufgaben

• Lead and mentor validation program managers and team leads.
• Deliver validation projects on time and within budget with appropriate validation approaches.
• Establish risk-based validation processes aligned with regulatory requirements.
• Oversee onshore/offshore validation contractors and timelines.
• Interface with Product Development, Operations, Security, and QA/Compliance.
• Plan periodic reviews of products and internal systems.
• Support audits and ensure compliance across product lines.

Kenntnisse

Team leadership

Project management

Validation strategy

GxP compliance

Technical writing

Risk-based validation

Communication

Ausbildung

B.S. in engineering/sciences

Tools

Automated testing tools

Jobbeschreibung

Veeva Systems is a mission-driven SaaS leader in life sciences. The Director of Computer Systems Validation Program will oversee validation teams, ensuring on-time, on-budget delivery across software validation, audits, and AI-driven capabilities.

The role emphasizes risk-based approaches, regulatory compliance, and leadership of multi-site teams. The position offers flexible work options as a Work Anywhere company, with responsibilities spanning planning, validation strategy, and