Scope

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.
 

Your mission

You will report and work in close collaboration with the Compliance Director.

In this role you will lead, mentor and support QA team members, this implies:

  • Managing the day-to-day activities of QA team

  • Sending clear status and escalating any issues to Management

  • Managing all HR aspects:

    • Building a challenging and motivation environment

    • Conducting employee training and evaluation

    • Providing support during the hiring and onboarding process

    • Resolving conflicts

  • Overseeing all aspects of Quality Assurance including:

    • Ensuring that processes and procedures needed for an effective Quality Systems are established, implemented and maintained

    • Maintaining documentation throughout the QA process

    • Establishing metrics (Monitoring Key Quality Indicators and Key Performance Indicators)

    • Troubleshooting

  • Acting as key point of contact for all QA aspects with internal stakeholders (Scientific operations, Sales, technics, …)

  • Acting as key point of contact for all QA aspects with external stakeholders (clients, authorities, …)

  • Managing and facilitating internal audits/assessments, client audits and regulatory inspections for the site

  • Supporting and promotign process improvement initiatives

  • Acting as Subject Matter Expert for Quality projects
     

Your profile

Scientific degree

Required

  • Background in quality to thoroughly understand processes in order to develop improved and effective procedures

  • Relevant experience in a similar role in the pharmaceutical industry

    • Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines

  • Very good written and verbal communication skills both in French and English

  • Computer literate

  • Effective leadership, organisational and management skills

  • Enthusiasm for solving problems, digging into issues and owning solutions

  • Desire for continuous improvement of process and technical practices

  • Conflict resolution skills

  • First experience in managing people

WHAT WE OFFER

  • A sector compliant remuneration package including numerous fringe benefits (luncheon vouchers, hospitalisation and ambulatory insurance, pension plan, etc.)

  • In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.