Remote Director of Validated IT Systems

Job Overview

We are seeking a highly skilled Director of IT Validated Systems to oversee the management and validation of GxP-related systems, ensuring adherence to regulatory standards. The successful candidate will demonstrate exceptional leadership qualities, superior communication skills, and a strategic approach to managing multiple projects. This hands-on role is critical in maintaining the utmost standards of quality and compliance across the organization.

Key Responsibilities

• Act as a strategic IT Business Partner to Quality, Clinical, and Regulatory teams, providing essential support for applications and ensuring compliance with internal protocols.
• Manage vendor and service provider relationships, including contract oversight and guidance throughout the validation process.
• Take responsibility for prioritizing enterprise and operational projects while maintaining effective communication channels.
• Collaborate with IT project managers to navigate resource and budget challenges, aligning projects with company objectives and IT budget constraints.
• Contribute to the formulation of IT PMO procedures, dashboards, and reports, fostering a data-driven decision-making environment.
• Lead a portfolio of compliance-oriented IT projects aimed at enhancing Risk-Based System Life Cycle (SDLC), GxP Compliance, and Audit Operational Preparedness.
• Oversee the continuous validation lifecycle of GxP-related systems, conducting thorough risk assessments.
• Partner with cross-functional teams and service providers to develop necessary SOPs, policies, and work instructions.
• Supervise Configuration and Change Management, Periodic Review, Audit Trail, Access Review, and Vendor Management processes for regulated systems.
• Represent the IT department during FDA Pre-Approval Inspections (PAI) and other regulatory audits.
  
  

Required Skills

• Extensive experience in validation engineering within the biotechnology or pharmaceutical industry.
• Proven expertise in leading IT projects and effectively managing teams.
• Strong knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system lifecycle management.
• Exceptional problem-solving abilities and adaptability to shifting priorities.
• Strong communication and interpersonal skills, promoting collaboration among cross-functional teams.
• Alignment with the company's values of compassion, boldness, rigor, and inclusivity.
  
  

Qualifications

• Bachelor's degree in IT, Engineering, Computer Science, or a related discipline.
• Significant experience in validation engineering and IT project leadership.
  
  

Career Growth Opportunities

Joining our organization presents a remarkable opportunity for professional development and career advancement within a dynamic environment that prioritizes quality and compliance.

Company Culture And Values

We take pride in fostering a diverse and inclusive workplace, ensuring that all candidates are evaluated based on their qualifications and experience without discrimination.

Compensation And Benefits

• Competitive base salary range: \(180,000 - \)220,000 per year, commensurate with qualifications, skills, and location.
• Additional discretionary bonuses and equity options included in the comprehensive compensation package.
• A robust benefits package featuring health and wellness programs and more.
  
  

Employment Type: Full-Time