Description:

Prilenia Therapeutics is seeking a Director/Senior Director, GCP Quality Assurance Lead to oversee GCP quality for clinical development in Huntington’s Disease and ALS.
The role involves end-to-end GCP quality management, serving as the primary QA lead for clinical operations and ensuring compliance with regulations and internal SOPs.

Requirements:

Bachelor’s degree in life sciences or related field; advanced degree preferred.
Minimum 10 years of GCP QA experience, with at least 3 years in a leadership role in biotech.
Expertise in GCP, GvP, and GLP quality frameworks; experience with regulatory inspections.
Proficiency with eTMF systems and electronic QMS platforms; exceptional communication skills.