CMC Quality By Design Project Manager
vor 1 Monat
This role is ideal for a seasoned professional in the pharmaceutical industry or high-tech sectors.
**Job Summary**
We are seeking an experienced Credit: https://prudential.com/regulated-professions/pharmaceuticals/high-technology-sectors, skilled project coordinator/project manager to lead small expert teams compiling quality by design and regulatory dossier information, along with directing digital improvement initiatives.
The successful candidate will possess 5+ years of experience working within life sciences, either as part of a pharmaceutical company (plasma, recombinant molecules, cell & gene therapy) or medtech/electronics field,
and expertise in:
• QbD process development
• Scale-up
• Technology transfer
• Process validation
• Regulatory affairs
• MS&TA digital expertise with hands-on experience focused on advanced data management/data processing/data analytics in life science areas.
Excellent communication skills are also crucial, enabling the effective interpretation, visualization, and dissemination of complex project data to facilitate collaborative decision-making and drive cross-functional business outcomes.
Knowledge of health authority regulations such as FDA, EMA, and PDMA is beneficial. Proficiency in English is necessary, while proficiency in German is desirable.
This role comes with an estimated salary of approximately $120,000 to $180,000 annually based on location and relevant experience. For further details regarding our comprehensive compensation package, please inquire about this opportunity.
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