CSV & IT Compliance Manager

Do you have a passion for quality and thrive in dynamic environments?

Are you a motivated and passionate Quality professional looking for an exciting new challenge?

If so, you might be the perfect fit for our Team at Ellab Italy, in Pero - Milan!

About the role

Ellab, a leading provider of innovative compliance solutions for the pharmaceutical and biotech industries, is experiencing rapid growth.

We are looking for a senior CSV & Compliance professional to lead validation projects for computerized systems in GxP-regulated environments. The role involves defining validation strategies, coordinating cross-functional teams, and supporting clients in achieving full compliance with international standards (GAMP 5, 21 CFR Part 11, Annex 11).

What you will be doing in this role?

With a strong focus on digital transformation and data integrity, you’ll drive innovation in validation processes while ensuring quality, efficiency, and regulatory alignment.

Your responsibilities will include:

• Define and oversee validation strategies for clients
• Coordinate CSV consultant teams and support training of junior resources
• Ensure quality and compliance of all deliverables
• Support regulatory inspections and client audits
• Drive innovation in validation processes through digital and paperless solutions

Skills and experience you will bring to Ellab

We are looking for a service minded colleague with a passion for improving quality processes with a keep it simple mindset. You have excellent collaboration skills and are self-driven, proactive, positive with a can-do attitude. You are a strong and natural communicator verbal as well as written and your work approach is structured and systematic.

Furthermore, we expect you to have:

Technical and Regulatory Expertise

• In-depth knowledge of international regulations and standards, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and ISO 9001
• Solid experience in the validation of computerized systems: ERP, LIMS, MES, SCADA, laboratory and manufacturing systems
• Strong command of the full CSV lifecycle: VMP, URS, FS, HDS, IQ, OQ, PQ, Risk Assessment, Change Control
• Ability to conduct audits, gap analyses, and compliance assessments in GMP-regulated environments
• Deep understanding of data integrity principles and electronic document management

Preferred Software Skills

• Ability to develop and customize software in regulated environments
• Hands-on knowledge of:
• VB.NET
• VBA
• SQL
• PowerApps
• Experience integrating digital solutions to manage and automate CSV processes

Cross-Functional and Managerial Skills

• Operational and strategic leadership of multidisciplinary teams and complex projects
• Strong client orientation with ability to understand needs and propose tailored solutions
• Effective communication with both technical and managerial stakeholders
• Advanced problem-solving skills, especially in regulated and high-compliance environments
• Project planning and multitasking capabilities, ensuring deadlines and budgets are met

Education and Experience

• Degree in a scientific or engineering discipline (e.g. Computer Science, Biomedical Engineering, Chemistry, Pharmacy)
• 7–10 years of proven experience in CSV, preferably in consulting firms or GMP-regulated industries
• Excellent command of written and spoken technical English

Commercial and Business Development Skills

• Ability to identify business opportunities and propose targeted consulting services
• Experience in client management and relationship building
• Aptitude for developing new projects in competitive markets
• Collaboration with the sales team to prepare technical and financial proposals

What we offer

• Competitive salary
• Opportunity to work in a global, dynamic and fast-paced environment
• Opportunity to influence your own tasks/responsibilities and develop your career in a supportive environment, making a real impact on a growing international company
• You’ll be joining a team highly focused on execution and optimization, while also recognising the importance of work-life balance.

The hiring process

If you find this opportunity exciting, apply today! We will review the applications as they come in and the interviews will be conducted ongoing.