Senior Risk & Compliance consultant

At customer site, Diegem
Regulatory Compliance
Professional, Freelancer

At the end of 2023, we acquired CTG, so their expertise and services are now also part of the Cegeka family. This acquisition strengthens our position and adds new areas of expertise to our portfolio, including IT solutions in Software Testing, IT Service Management and Regulatory Compliance. We are currently looking for experienced/senior Risk & Compliance Consultants for various projects in the Life Sciences sector. In order to guarantee patient safety, numerous regulations apply within Life Sciences. As a Risk & Compliance Consultant, you will help ensure that this patient safety and quality are monitored. Our consultants usually work on compliance projects within IT, but are equally well deployed in other departments and/or in an operational role. The combination of scientific knowledge and interest/experience in IT and automation within the Life Sciences sector is the unique character of our consultants and unit.

  • As a Risk & Compliance consultant, you will be responsible for planning, coordinating, implementing and reporting on Computer System Validation (CSV), QA/QC and/or IT-related compliance projects. You also act as a mentor and coach for your junior colleagues. You prepare high quality documentation. In addition, you work out procedures and provide support to end users. You perform assessments, gap analyses and risk analyses at the customer and you are adept at drafting improvement plans.

What you need to succeed:

  • You have a master's degree in sciences such as (bio)chemistry, pharmacy, biochemistry, biomedical sciences, bioengineering, or equivalent through experience.
  • You have at least 3 years of experience in compliance within regulated industries.
  • You have a good knowledge of applicable laws, regulations, industry standards and guidelines (GxP, 21 CFR Part 11, GAMP....). Knowledge of ISO standards (9001, 27001) is a plus.
  • You work fluently with MS Office.
  • You have a strong work ethic, keeping your appointments punctually, being flexible and working pragmatically and accurately. Quality is an absolute priority for you.
  • Throughout your career, you have gained project management experience and have evolved as a strategic thinker with strong analytical and problem-solving skills who can translate client needs into concrete and effective actions.
  • You are a team player who can also work well independently. For this you use your communication skills, both in English and Dutch and possibly French

What are we offering:

  • We ask a lot (talents) of you. Fortunately, you also get a lot in return! Competencies and character are essential to us, in addition to experience and ambitions. Cegeka continuously invests in talent management so that every employee can realize his potential.
  • You start at a Top Employer!
  • An attractive salary package including a company car with fuel card, meal allowance, representation allowance, a group insurance (including pension savings) and 12 labour reduction days. 
  • Flexible working hours and possibility to work from home depending on your role or project.
  • Customized guidance: throughout your career you will be guided by our People managers. So you have a contact person, a personal coach and a sparring partner.
  • Continuous learning: through internal and external training, we focus on knowledge sharing and learning.
  • Opportunity for growth: depending on your own interests and initiatives, Cegeka offers various horizontal and vertical career paths.
  • We value sustainability by pursuing CO2 neutrality with the electrification of our vehicle fleet and an environmentally friendly data center. We develop innovative solutions with a positive impact on the environment, people and society, and strive for an inclusive and diverse work environment where everyone is valued and heard.

Aspire to more: our promise to you!

At Cegeka you get all the opportunities you need to develop further as a professional. Together we discover what you really want to do for our clients and colleagues. We would like to invite you to grow with us. In an unprecedented variety of challenging and meaningful IT projects. Make your mark on projects with interesting customers where we can make the difference. Aspire to more!

We are always working together here. Intensively, with lots of fun and commitment. It is a culture driven by family values: full of trust, people-oriented, open, loyal and respectful. We offer a lot of freedom and responsibility. We want you to be part of the next phase of a proud, successful, fast-growing, innovative, European IT company full of ambitions.

Application flow

Do you have any questions about this role?

Let's connect.