OverviewDo 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 responsibilitiesDefine 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 EllabWe 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 ExpertiseIn-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 SkillsAbility 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 SkillsOperational 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 ExperienceDegree 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 SkillsAbility 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 offerCompetitive 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 processIf you find this opportunity exciting, apply today!
We will review the applications as they come in and the interviews will be conducted ongoing.
#J-18808-Ljbffr