IT Business Partner, R&D, Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a strategic and operational link between R&D functions and IT.

• Serve as the main IT collaborator for specific R&D functions, such as Regulatory Affairs, Quality, and Clinical Development.

• Develop and sustain account and relationship strategies.

• Oversee the strategy, roadmap, and lifecycle management for Veeva R&D systems, which include Veeva Vault QMS and Veeva Vault RIM.

• Convert business and regulatory priorities into actionable technology plans, effort assessments, and prioritization within IT investment cycles.

• Lead or manage system configuration, validation, and change control activities for Veeva platforms in a GxP-regulated setting.

• Collaborate with Quality and Regulatory stakeholders to address evolving compliance requirements, including 21 CFR Part 11, GxP, and global submission standards.

• Create business cases for platform enhancements, integrations, and new functionalities; manage the associated budgets.

• Work alongside enterprise architecture, data, and security teams to incorporate Veeva and related R&D systems as global solutions.

• Cultivate relationships with Veeva and other third-party vendors and implementation partners.

• Provide updates on project status, risks, and escalations to IT and R&D leadership.

• Guide junior IT business partners or analysts who support the Veeva platform portfolio.

• Identify prospects for automation, AI/ML, or process enhancements within QMS/RIM workflows.

• Report directly to the Chief Financial Officer.

⛳️ Requirements

• A Bachelor's degree in IT, Life Sciences, or a related field.

• Minimum of 8 years in a client-facing IT position within the pharmaceutical or biotech sector, demonstrating increasing levels of responsibility.

• Proven experience in managing global regulatory compliance.

• Practical experience with Veeva Vault QMS and Veeva Vault RIM, including configuration, validation, or business ownership.

• Strong comprehension of GxP-regulated environments.

• Familiarity with computer system validation (CSV/CSA).

• Understanding of change control processes.

• Experience with regulatory submission and/or quality management processes in pharmaceutical R&D.

• Capability to translate business and regulatory requirements into technical specifications and delivery plans.

• Excellent stakeholder management and communication skills across technical, scientific, and regulatory audiences.

• Experience in developing business cases and managing project or platform budgets.

• Veeva-specific certifications, such as Veeva Vault QMS or RIM Administrator, are advantageous.

• Experience in post-market compliance is a plus.

• Ability to exemplify Elevar's core values, including accountability, collaboration, ingenuity, and compassion.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Time off.

• Retirement plan.

• Additional voluntary benefits.

• Remote work arrangement.