CSV Manager F/M/X

Job description

Amaris Consulting is looking for an experienced CSV (Computer System Validation) Manager with 7 to 12 years of experience to join our dynamic team in Brussels under a long\-term international project. In this role, you will lead Computer System Validation activities within a pharmaceutical environment and contribute to ensuring compliance, quality, and operational excellence across regulated systems.

Your Responsibilities:

Lead and oversee CSV activities for regulated pharmaceutical systems and applications

Define and implement validation strategies aligned with GxP and regulatory requirements

Coordinate validation lifecycle activities including risk assessments, test strategies, execution, and documentation

Collaborate with cross\-functional teams including QA, IT, Business, and external stakeholders

Ensure compliance with industry regulations such as FDA 21 CFR Part 11, GAMP5, and Annex 11

Review and approve validation deliverables, deviations, CAPAs, and change controls

Support audits and inspections by preparing validation documentation and providing expert guidance

Drive continuous improvement initiatives related to validation processes and compliance standards

Mentor and support junior team members within the validation domain

Your Profile:

Bachelor’s or Master’s degree in IT, Engineering, Life Sciences, or a related field

7 to 12 years of experience in Computer System Validation within the pharmaceutical industry

Strong knowledge of GxP environments, CSV methodologies, and regulatory standards

Hands\-on experience with validation of regulated systems, infrastructure, and applications

Experience working in international and cross\-functional environments

Fluent in English and French, both written and spoken

Strong communication, leadership, and stakeholder management skills

Ability to work autonomously while managing multiple priorities in a fast\-paced environment

What We Offer:

A truly international and multicultural work environment.

Access to training programs and certifications to accelerate your development.

An R\&D lab where you can explore new technologies and approaches.

The opportunity to propose and lead innovative ideas within the company.

Personalized coaching and mentoring from experienced professionals.

A tailor\-made career path, aligned with your growth ambitions.

Why Join Amaris Consulting?

Agility: Work in a dynamic, flexible, and stimulating environment.

International exposure: Collaborate with teams in over 60 countries and enjoy mobility opportunities.

Intrapreneurship: Take ownership of your ideas or create your own Business Unit.

Supportive management: Your manager will guide you based on your individual profile and goals.

Amaris Consulting is proud to be an equal\-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System \& Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 \- the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem\-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

Cette annonce provient de indeed. Voir l'annonce originale ↗