Principal IT System Site Lead (GMP)

Evotec•Redmond, WA

2d•Onsite

About The Position

The Principal GMP IT System Site Lead is a senior-level IT role ensuring that computerized systems used in regulated environments (pharmaceutical, biotech, medical device) comply with GxP Regulations and data integrity standards. This role leads system validation, gathers requirements, configures software, and manages system lifecycles while bridging the gap between IT, quality departments, and business stakeholders.

Requirements

10+ years of experience in systems analysis, with strong expertise in GxP/regulated environments.
Proficiency with Computer System Validation (CSV) and Data Integrity requirements.
In-depth understanding of FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.
Excellent analytical skills, technical writing, vendor management, and project management capabilities.
Bachelor’s degree in Computer Science, Information Technology, or a relevant scientific field (e.g., Biology, Chemistry).

Responsibilities

Oversee the maintenance, upgrade, and management of IT infrastructure, including networks, servers, databases, and software applications.
Ensure robust cybersecurity measures are in place to protect data and IT resources.
Manage and deliver site specific IT projects on time and within budget. This includes planning, executing, monitoring, and closing projects.
Negotiate with and manage relationships with technology vendors and service providers to ensure cost-effective and high-quality solutions.
Develop and implement IT policies, procedures, and best practices. Ensure compliance with legal and regulatory requirements.
Leads Computer System Validation (CSV) projects, including creating validation plans, scripts, and reports (IQ/OQ/PQ) to ensure compliance with 21 CFR Part 11 and GxP guidelines.
Translates complex user requirements into functional and technical specifications for laboratory or manufacturing systems.
Performs hands-on configuration, system administration, and technical troubleshooting for GMP/GLP systems.
Creates and updates standard operating procedures (SOPs), technical manuals, and data integrity documents.
Manages change control requests for validated systems, conducting risk assessments to maintain the validated state.
Mentors junior analysts and acts as a key liaison between software vendors and internal business units.