Remote Director of IT Systems Validation | WFH

Job Overview

We are in search of a Director of IT Validated Systems to spearhead the management and validation of GxP-related systems, guaranteeing strict adherence to regulatory standards. The successful candidate will exhibit strong leadership qualities, exceptional communication skills, and a strategic outlook, along with the capability to prioritize and oversee multiple projects efficiently. This role demands an active involvement to ensure that the highest benchmarks of quality and compliance are consistently met across the organization.

Key Responsibilities

• Act as an IT Business Partner to Quality, Clinical, and Regulatory teams, offering support for applications and ensuring compliance with internal policies and procedures.
• Manage vendor and service provider partnerships, overseeing contracts and steering the validation process.
• Assume responsibility for prioritizing both enterprise and operational projects, maintaining a high level of communication.
• Collaborate with IT project managers to resolve resource and budget challenges, ensuring alignment with organizational objectives and IT budget constraints.
• Contribute to the formulation of IT PMO procedures, dashboards, and reports.
• Offer data-driven insights to stakeholders, ensuring adherence to best practices throughout projects.
• Lead a portfolio of compliance-centric IT initiatives to enhance Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness.
• Ensure the ongoing validation of GxP-related systems, managing their lifecycle and executing risk assessments.
• Collaborate with teams and service providers to establish necessary SOPs, policies, and work instructions.
• Oversee 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

• Extensive experience in validation engineering within the biotechnology or pharmaceutical sector.
• Proven success in leading IT projects and effectively managing teams.
• Comprehensive understanding of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management.
• Strong problem-solving abilities and adaptability to evolving priorities.
• Exceptional communication and interpersonal skills, fostering collaboration with cross-functional teams.
  
  

Qualifications

• Bachelor's degree in IT, Engineering, Computer Science, or a related field.
• Significant experience in validation engineering specifically within the biotechnology or pharmaceutical industries.
• Demonstrated history of successfully leading IT projects and team management.
  
  

Career Growth Opportunities

We are committed to supporting professional development, offering hands-on experience in leading IT initiatives and team management, which can facilitate growth within the biotechnology and pharmaceutical sectors.

Company Culture And Values

Our organization champions compassion, boldness, rigor, and inclusivity, cultivating a collaborative environment where team members join forces to achieve common objectives.

Compensation And Benefits

• Base salary range: \(180,000 - \)220,000 per year (based on qualifications, skills, and location).
• Additional discretionary bonuses and equity options are part of the total compensation package.
• A comprehensive benefits package, including health and wellness programs, is available.
  
  

Equal Opportunities

We are an equal opportunity employer, dedicated to promoting diversity and inclusion. All applicants are evaluated based on qualifications, skills, and experience without any form of discrimination.

Sponsorship

Please note that we are currently unable to sponsor employment visas. Candidates must have the right to work in the country of application.

Employment Type: Full-Time