IT Compliance Lead — Senior CSV | Pharmaceutical
📍Brabant wallon, Belgium.
Introduction
Nalys is hiring — and this one's for the CSV expert who leads from the front.
Nalys is a Belgian recruitment and consultancy firm specialised in the pharmaceutical, biotech and life sciences industries. With deep expertise across quality, regulatory affairs, manufacturing, engineering and clinical development, we support both large international groups and innovative scale-ups in building the teams that drive their projects forward. When we place a professional, we stay by their side — before, during and after the mission.
Today, we're looking for a senior IT Compliance Lead with deep Computer System Validation expertise to step into a high-responsibility role within an established IT Compliance team in the Brabant wallon area.
This is a replacement mission — you'll be expected to hit the ground running, take full ownership of your scope, and lead validation strategy across clinical and pharmacovigilance environments with complete autonomy.
Your Responsibilities
As the new Senior CSV, you will :
* Define validation strategies and compliance approaches for GxP-regulated computer systems
* Lead stakeholder discussions, drive decisions and ensure alignment across IT, Quality and business functions
* Supervise CSV activities and maintain regulatory compliance across the system portfolio
* Monitor compliance levels, define and improve IT validation processes
* Support audits and regulatory inspections with confidence and technical depth
* Guide and coach team members on CSV methodology and compliance standards.
Your Profile
* You have minimum 8 years of experience in Computer System Validation in a pharmaceutical or life sciences environment
* Deep knowledge of GxP regulations — GMP, GCP and associated frameworks
* You are experienced in defining and owning validation strategies — not just executing them
* You are assertive, confident and comfortable leading discussions with senior stakeholders
* You work with a strategic mindset — you see the full picture and translate it into actionable compliance frameworks
* Strong leadership and decision-making capabilities — you drive change, you don't wait for it
* You are able to work fully autonomously from day one — no coaching capacity is available in this role
* Fluency English is mandatory — all documentation and stakeholder interactions are in English
* French is a useful asset for day-to-day site interactions
* Experience with clinical or pharmacovigilance systems (Veeva, Argus or equivalent) is a strong asset.
What We Offer
* A human‑scaled consulting company focused on expertise, partnership, and career development
* Long‑term assignments with leading pharmaceutical players
* Continuous learning through technical coaching, training, and knowledge sharing
* A supportive culture that values autonomy, trust, and impact
* An attractive salary package with additional benefits.
Our Recruitment Process
When applying for this position at Nalys, you can expect a clear and engaging recruitment journey:
* Talent Acquisition Call
A first discussion with our Talent Acquisition Specialist, Olivia Braszko, to understand your background, motivations, and career goals
* Technical Interview
A meeting with one of our Technical Referent to evaluate your expertise and fit for the mission
* Business Interview
* A conversation with the Business Unit Director, Jimmy Rousseaux, to discuss the project context and your future within Nalys.
Interested?
👇 Please apply directly via this post and go for a first discussion !