Senior Gcp Quality Assurance Lead 3095101 I.Html

Leading GCP quality assurance efforts, the full-time Senior GCP Quality Assurance Lead will provide end-to-end oversight for clinical programs, ensuring compliance with regulatory requirements while supporting quality activities across pharmacovigilance and pre-clinical areas in a remote setting.

##### Key responsibilities

Act as the primary QA lead for clinical programs, overseeing GCP compliance from study initiation to inspection readiness

Manage preparation for global regulatory inspections and coordinate responses to inspection findings

Conduct audits of clinical sites and vendors, ensuring adherence to quality standards and implementing corrective actions

##### Required qualifications

Bachelor's degree or higher in Life Sciences, Pharmacy, or a related discipline

Extensive experience in GCP Quality Assurance within biotech, pharmaceutical, or CRO environments

Strong knowledge of GCP, GVP, and GLP frameworks, along with ICH guidelines and global regulatory requirements

Proven experience leading or supporting regulatory inspections

Experience with eTMF systems and electronic QMS platforms