Remote Director of IT Validated Systems | WFH

Job Overview

We are in search of 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 exhibit exceptional leadership qualities, outstanding communication abilities, and a strategic mindset, along with the capacity to prioritize and manage a variety of projects efficiently. This position requires an involved approach to guarantee the utmost standards of quality and compliance throughout the organization.

Key Responsibilities

• Act as an IT Business Partner to Quality, Clinical, and Regulatory teams, delivering support for applications and confirming compliance with internal policies and procedures.
• Manage vendor and service provider relationships, including contract oversight and direction of the validation process.
• Assume responsibility for prioritizing both enterprise and operational projects while maintaining high-quality communication.
• Collaborate with IT project managers to navigate resource and budget challenges, ensuring alignment with corporate objectives and IT budget limitations.
• Aid in the development of IT PMO procedures, dashboards, and reports.
• Provide data-informed recommendations to stakeholders, guaranteeing adherence to best practices throughout project execution.
• Lead a portfolio of compliance-centric IT initiatives aimed at enhancing the Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness.
• Oversee the ongoing validation of GxP-related systems, managing their lifecycle and conducting comprehensive risk assessments.
• Work in tandem with teams and service providers to formulate required SOPs, policies, and operational instructions.
• Supervise Configuration and Change Management, Periodic Review, Audit Trail, Access Review, Periodic Restore, and Vendor Management processes for regulated systems.
• Represent the IT department during FDA Pre-Approval Inspections (PAI) and other regulatory audits.
  
  

Required Skills

• Proven leadership and project management capabilities.
• Superior communication and interpersonal skills.
• In-depth knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management.
• Strong problem-solving abilities and flexibility in adapting to shifting priorities.
• Demonstrated capacity for effective collaboration with cross-functional teams.
• Alignment with the core values of compassion, boldness, rigor, and inclusivity.
  
  

Qualifications

• Bachelor's degree in IT, Engineering, Computer Science, or a related discipline.
• Extensive experience in validation engineering within the biotechnology or pharmaceutical sectors.
• A proven history of leading IT projects and managing teams effectively.
• Strong understanding of GxP compliance and relevant FDA regulations.
  
  

Career Growth Opportunities

This role presents a unique opportunity for professional advancement, allowing you to spearhead vital IT projects within the biotechnology and pharmaceutical industries. Your leadership will play a critical role in enhancing compliance and risk management frameworks, paving the way for future growth within the organization.

Company Culture And Values

Our organization is committed to fostering a culture that emphasizes compassion, boldness, rigor, and inclusivity. We prioritize collaboration and teamwork, promoting partnerships across functions and encouraging transparent communication among all teams.

Compensation And Benefits

• Base salary range: \(180,000 - \)220,000 annually (commensurate with qualifications, skills, and location).
• Availability of additional discretionary bonuses and equity options as part of the overall compensation package.
• A comprehensive benefits package, including health and wellness programs, and more.
  
  

Employment Type: Full-Time