Demo

IT Validated Systems Director - Remote | WFH

Get It - Professional Services
New York, NY Remote Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 3/9/2025
Job Overview

We are seeking a highly qualified Director of IT Validated Systems to oversee the management and validation of GxP-related systems, ensuring adherence to regulatory compliance standards. This pivotal role calls for a dynamic leader with exceptional communication abilities, a strategic outlook, and the capacity to effectively juggle multiple projects. A hands-on approach is essential in maintaining the highest quality and compliance standards across our organization.

Key Responsibilities

  • Act as an IT Business Partner for the Quality, Clinical, and Regulatory teams, facilitating support for applications while ensuring compliance with internal standards.
  • Manage vendor and service provider partnerships, overseeing contracts and guiding the validation process.
  • Prioritize and take ownership of enterprise and operational projects, maintaining open lines of communication.
  • Collaborate with IT project managers to resolve resource and budgetary challenges, ensuring alignment with organizational objectives and IT budget constraints.
  • Contribute to the formation of IT PMO procedures, dashboards, and reporting mechanisms.
  • Provide data-driven insights to stakeholders to ensure adherence to best practices in project execution.

Required Skills

  • Comprehensive understanding of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management.
  • Strong analytical and problem-solving capabilities, with the ability to adapt to shifting priorities.
  • Excellent interpersonal skills, fostering collaboration with cross-functional teams.
  • Proven experience in leading IT projects and effectively managing teams.
  • A commitment to the principles of compassion, boldness, rigor, and inclusivity.

Qualifications

  • Bachelor's degree in IT, Engineering, Computer Science, or a related discipline.
  • Extensive validation engineering experience within the biotechnology or pharmaceutical sectors.
  • Demonstrated success in leading IT initiatives and managing team dynamics.

Career Growth Opportunities

Our organization places a strong emphasis on professional development, providing numerous opportunities for skill enhancement and career advancement. In this role, you will contribute to critical project management procedures and reporting, further developing your leadership capabilities.

Company Culture And Values

We pride ourselves on fostering an inclusive work environment that emphasizes collaboration, innovation, and shared success. Our core values of compassion, boldness, rigor, and inclusivity guide our interactions and decision-making processes.

Compensation And Benefits

  • Base salary range: \(180,000 - \)220,000 per year (commensurate with qualifications, skills, and geographic location).
  • Options for discretionary bonuses and equity as part of the overall compensation package.
  • A comprehensive benefits package that includes health and wellness programs, among other offerings.

Employment Type: Full-Time

Salary : $180,000 - $220,000

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