Principal IT System Site Lead (GMP)

Job title: Principal IT System Site Lead (GMP)

Principal GMP IT System Site Lead is a senior-level IT roleensuring that computerized systems used in regulated environments (pharmaceutical biotech medical device) comply withGxP Regulations and data integrity standards. They lead system validation gather requirements configure software and manage system lifecycles while bridging the gap between IT quality departments and business stakeholders.

What Youll Do:

• IT Infrastructure and Security: 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.

• Project Management: Manage and deliver site specific IT projects on time and within budget. This includes planning executing monitoring and closing projects.

• Vendor Management: Negotiate with and manage relationships with technology vendors and service providers to ensure cost-effective and high-quality solutions.

• Policy and Procedure Development: Develop and implement IT policies procedures and best practices. Ensure compliance with legal and regulatory requirements.

• System Validation & Compliance: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.

• Requirements Gathering & Analysis:Translates complex user requirements into functional and technical specifications for laboratory or manufacturing systems.

• System Configuration & Support:Performs hands-on configuration system administration and technical troubleshooting for GMP/GLP systems.

• Documentation & SOPs:Creates and updates standard operating procedures (SOPs) technical manuals and data integrity documents.

• Change Control & Risk Management:Manages change control requests for validated systems conducting risk assessments to maintain the validated state.

• Strategic Leadership:Mentors junior analysts and acts as a key liaison between software vendors and internal business units.

Who You Are:

• Experience: 10 years of experience in systems analysis with strong expertise in GxP/regulated environments.

• Technical Knowledge:Proficiency with Computer System Validation (CSV) and Data Integrity requirements.

• Regulatory Knowledge:In-depth understanding of FDA 21 CFR Part 11 EU Annex 11 and ICH guidelines.

• Skills:Excellent analytical skills technical writing vendor management and project management capabilities.

• Education: Bachelors degree in Computer Science Information Technology or a relevant scientific field (e.g. Biology Chemistry).

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.

• A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec!

The base pay range for this position at commencement of employment is expected to be $145000 to $170000; Base salary offered may vary depending on individuals skills experience and competitive market value.

Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.