Your responsibilities will be the following:

• Run small Expert Teams to compile Quality by Design and regulatory dossier information.
• Compile Quality by Design information.
• Compile CMC regulatory dossier information & PACMP protocols / reports.
• Enable/direct internal department digital improvement initiatives encompassing interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
• Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives.

Your profile:

• 5+ years’ experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (Med Tech, electronics)
• Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe.
• Qb D process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
• A digital expertise with hands-on experience focused on advanced data management / data processing / data analytics in a life science area
• Have experience in interpreting, visualising and communicating complex project data to facilitate collaborative decision-making driving cross-functional business outcomes
• Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
• English spoken & excellent writing skills required
• German spoken & written is an asset

Qui sommes nous ?
Since 2005, the largest laboratories have renewed their trust in us. Specialized in pharmaceuticals, biotechnology and medical devices, we support our clients from R&D to the market launch of their products.

Human-scale company, belonging to the Vulcain Engineering Group, we are committed to supporting and advancing our employees who are recognized for their technical and scientific expertise. Through our regional subsidiaries, we guarantee each one a geographical stability, without mobility clause on the main basins of activities in France, Belgium, Switzerland, Denmark and Canada.

At Consultys, we prove that it is possible to combine Human and Performance.

Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group’s success.

Most of Consultys:

• Stable, senior teams that accompany you in taking charge of your position

• Tailor-made training tailored to your career prospects

• The guarantee of working close to you, without geographical mobility